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LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

NEW DRUG LIST 1961‐ SEPTEMBER 2017

PHARMADOCX (Pharma Consultant)

Consultant for Setting up:

Pharmaceuticals, Cosmetics, Medicals Devices, Bandages and Diagnostic Kit Factory, WHO GMP.

Office. : Opp. Dewan Mill,Old D.C. Road, Sonepat-131001 Ph. 0130-2200630, (M) +91-9896133556 E-mail : [email protected] Web : www.pharmadocx.com

PHARMADOCX CONSULTANT 1 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

COMPMANY PROFILE Founded in 2007, Pharmadocx is India based firm providing consultation services to Pharmaceutical, Cosmetics, Medical Devices & related Industries. Our Activities:‐ 1. To provide layout of plant in AutoCAD format as per Schedule M, & WHO‐GMP guidelines to manufacture Medical Devices. The layout will include dimensions of each room & height as per machine height. It will include type of false ceiling (material of construction) / service floor to be provided, lighting & other electrical location in it. We will guide areas where GMP panels & where brick walls are to be used. Guide to select several types of GMP panels which are available e.g. PCGI Sheet panel (Powder Coated Galvanized Iron Sheet) or PPGI ( Pre Painted Galvanized Iron Panels). These panels can be PUF filled or Honey Comb filled as per your choice. Door size & opening direction will be decided as per usage. View panels, pass boxes will be provided on the walls as requirement. Type of flooring to be done viz. Kota Stone, Epoxy, PU Sheet etc. This layout you will send to your vendor for BOQ & quotation. 2. To provide plumbing layout for Raw Water, Purified Water, Air Etc. GMP Drains, their size as per usage. ETP, capacity to be installed, Raw Water Tank Capacity, RO & Purified Water plant & their storage tank make & capacity. 3. To provide in the layout electric points for machines, pass boxes, LAF, Fly killer, general lighting etc. To calculate total electric load of company, capacity of transformer, diesel generator, location of Electrical Panels. Selection of LED lights as per LUX level required. 4. To provide list of machine & instruments required, provide proper location for machines in layout, to provided source of machines with prices. 5. To approve all the drawings, quotation received from vendors. 6. To provide Design qualification & URS (User Requirement Specification) of air handling unit along with details of class, pressure differential, temperature, air changes etc. required for production & laboratory. 7. To ensure that premises are constructed as per latest norms.

PHARMADOCX CONSULTANT 2 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Liaison Work To prepare all the documents required to be enclosed with licence application. To submit application. To follow application & get audit done. To give reply to query raised by Department. Finally get Manufacturing Licence Granted.

GMP Documentation Work To perform gap analysis & to provide all the documents required for maintaining records as per Schedule M, Schedule U & WHO‐GMP guidelines which consists of Standard Operating Procedure for all machines, SOP in Hindi, Validation, Master Formula, HACCP Risk analysis, Change Control, Raw Material, Packing Material & Finished Goods Stock register, Log Books, Cleaning & Sanitization record, Training Record, Over Head Tank Cleaning Record, Under Test, Approved & Rejected Labels, In process Material Status Labels, Etc. & many more.

PHARMADOCX CONSULTANT 3 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Note:- While all efforts have been made to make this list alphabetical but due to technical reasons all items are not alphabetical. Users shall search its pdf for better results. ABACAVIR 22.03.2002 Each 5 ml of reconstituted suspension contains: 18.09.14 Amoxicillin Trihydrate IP eq to Amoxicillin 200 mg/400 mg + Potassium Clavulanate IP Eq to Clav ulanic acid 28.5 mg / 57 mg (additional Strength) “Added inadvertently” 19.03.15 Dried Ferrous Sulphate Enteric Coated IP 150mg eq. to Elemental Iron 45 mg Folic acid 0.4 mg (Additional strength) Each enteric coated tablet contains: (I) Rice based ORS citrate containing each sachet: Nacl 3.5g+KCl 1.5g+Sodium Citrate 9.12.1993 2.9gm+Extruded Rice 50.0gm. (II) Rice based ORS electrolytes containing each sachet: Nacl 1.25gm+ KCl 1.50gm+Sodium Citrate 2.90gm+ Extruded Rice 50.0gm 1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg & FDC of Tenofovir 19-07-10 Disoproxil fumarate 300mg + Lamivudine 300mg (Each Co-pack contains :- 1 capsule of Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of Tenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg) 1 tablet of Atazanavir 300mg & 1 tablet of ritonavir Ritonavir 100mg 19-07-10 & FDC of Tenofovir Disoproxil fumarate 300mg + Lamivudine 300mg (Each Co-pack contains :- 1 capsule of Atazanavir 300mg & 1 Tablet of Ritonavir 100mg & 1 Tablet of FDC of Tenofovir Disoproxil Fumarate 300mg + Lamivudine 300mg) 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of Nevirapine 200mg 23-06-2010 combipack 1 tablet of Tenofovir disoproxil 300mg + Lamivudine 300mg & 2 tablet of Nevirapine 200mg 23-06-2010 combipack 1-(2-tetrahydrofuryl)-5- Fluorouracil June-1977 1) Triticum Vulgare Topical Cream Each 100gm of cream contains: 14.11.2009 Aqueous extract of Triticum Vulgare (dry residue 200mg / 100ml) ..... 15gm 2-phenoxyethanol Eur. Ph.....1gm 2) Triticum Vulgare Vaginal Pessary Each 3.5gm of vaginal pessary contains: Aqueous extract of Triticum Vulgare (dry residue 200mg/ 100ml) .....0.60gm 2-phenoxyethanol Eur. Ph.....0.04gm 1,2-Dimethyl-3 Hydroxypyrid- 4-one 250mg/500mg Capsule 7-12-1994 1. PROBIO : Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 Billion CFU 09.06.11 (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) 2. PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii); Fructo Oligo Saccharides …. 100mg 3. PROBIO & PREBIO (D); Each sachet (1.3g) contains: Probio (CMP 5); Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii); Fructo Oligo Saccharides...1000mg

PHARMADOCX CONSULTANT 4 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

1. PROBIO : 09.06.11 Each sachet (1g) contains: Total Probiotic.... Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) 2. PROBIO & PREBIO (F)s Each sachet (1g) contains: Probio (CMP 5) Total Probiotic...Not less than 1.25 Billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides …. 100mg 3. PROBIO & PREBIO (D) Each sachet (1.3g) contains: Probio (CMP 5) Total probiotic... not less than 1.25 billion CFU (Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Saccharomyces boulardii) Fructo Oligo Saccharides...1000mg 1-Nicotinylamine-1,2- Diphenylethane (Bulk) June-1969 2% premix contains; 40gm of Virginiamycin, 50% granules per kg (For Veterinary) July-1975 22.5mg Injection (Lyophilized power for suspension for injection, Intramuscular Route) Additional Strength 2-Bromo-2-Nitropropan-1,3- diol September-1972 2-Bromo-2-nitropropan-3-diol April-1975 2-Pyrrolidone Acetamide December-1977 2-Pyrrolidone acetamide- 200mg/2ml Injection January-1978 2-Pyrrolidone acetamide- 400mg Capsule January-1978 2-Sulphanilamide-5-Methyl January-1970 2-Thymyloxy Methyl Glyoxalidine Hcl. (0.05%) Nasal drops November-1961 2-Thymyl-oxy-methyl glyoxalidine Hydrochloride January-1971 0.05 + Buffered Aqueous Vehicle- q.s (Nasal Spray) 3,5 - Dinitro-O-Toluamide (For Veterinary) January-1972 3-Methyl Pyrantel Tartrate (4%) Oral Solution (For Veterinary) May-1970 3-Methyl Pyrantel Tartrate (Veterinary purpose) April-1970 3-Phenylazo-2,6- Diaminopyridine (Bulk) May-1969 Abacavir Sulfate Tablet 60mg 1.08.2009 Abacavir Sulphate IP eq .to Abacavir 60mg Lamivudine IP 30mg 09.06.2017 (Additional strength) Each film coated tablet contains: Abacavir Sulphate syrup 20mg/ml 29-08-06 Abatacept Injection 250mg/vial (additional indication) 10.04.09 Abatacept Injection 250mg/vial (Addl. Indication) 20.02.09 Abatacept powder for injection 250mg/vial 22.07.08 Abciximab 10mg/5ml vial Injection 2-5-1997 Abiraterone Acetate Tablet 250 mg 12.08.2016 (Additional Indication) Abiraterone Acetate Tablet 500 mg 12.07.2017 Abiraterone acetate Tablet 27.03.15 250 mg (Additional Indication) Abiraterone Acetate Tablets 250mg 16.12.11 Acamprosate Calcium 30.10.2002 Acarbose 25mg/50mg + Metformin 500mg/500mg FC Tablet 23.02.2009 Acarbose 50mg/100mg Tablet 6-3-1997 Acebrophylline capsules 100mg 29.05.08 Acebrophylline SR Tablet 200 mg 23.11.10

PHARMADOCX CONSULTANT 5 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Acebrophylline Syrup 10mg/ ml 09.01.09 Acebrophylline Syrup 10mg/ml (Additional Indication) 30.03.09 5mg/ml Injection December-1985 Acebutolol HCl 200mg + HCTZ 12.5mg Aug-86 Acebutolol Hcl December-1985 100mg/200mg/ 400mg Capsule Aceclofenac 15-09-2003 Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin gel 06-08-2005 Aceclofenac (100 mg) + Paracetamol(500 mg) 29-06-2004 Aceclofenac 1% w/w + Menthol 5% Spray 28-05-2010 Aceclofenac 1% w/w + Menthol 5% Spray 28-05-2010 Aceclofenac 100mg + 2mg film coated tablets 23.02.09 Aceclofenac 100mg 23.02.09 + Tizanidine 2mg film coated tablets Aceclofenac 100mg+Paracetamol 500mg tablets 08.07.2004 Aceclofenac 200mg (S.R) tablet 22-02-2006 Aceclofenac 200mg/200mg SR + Rabeprazole 10mg/20mg Capsule 01.07.2009 Aceclofenac dispersible tablet 100mg (new dosage form) 21-12-06 Aceclofenac gel 1.5% alongwith linseed oil, menthol, Salicylate, Capsaicin 08-06-2005 Aceclofenac Inj. (150mg/ml) 28-09-06 Aceclofenac Inj. 50mg/ml (additional strength) 1-12-2006 Aceclofenac injection (150mg/3ml) 19.02.07 Aceclofenac injection 150mg/ml 23.01.08 Aceclofenac IP (Sustained released pellets) 200mg/200mg + Thiocolchicoside IP (Sustained 04.01.12 released pellets) 8mg/16mg Capsules. (New Dosage Form) Aceclofenac IP (Sustained released pellets) 200mg/200mg + Thiocolchicoside IP (Sustained 04.01.12 released pellets) 8mg/16mg Capsules. (New Dosage Form) Aceclofenac Roll - On 1% 24.10.08 Aceclofenac(100mg) + Thiocolchicoside (4 mg) tablets (Additional strength) 11.08.2009 Aceclofenac(100mg) +Thiocolchicoside (8 mg) tablets 3.08.2009 Aceclofenac(100mg) + Thiocolchicoside (4 mg) tablets (Additional strength) 11.08.2009 Aceclofenac(100mg) + Thiocolchicoside (8 mg) tablets 3.08.2009 Acesulfame Potassium 05-04-2005 Acetyl Cysteine Eye Drops 5% w/v 14.12.2010 Acetyl salicylic acid 100mg + Cal. Carbonate 30mg + Anhydrous citric acid 10mg Tablet Sep-91 Acetylcystein Injection March-1966 Acetylsalicyclic acid 350mg + Al. Hydroxide 90mg + Mg. Hydroxide 90mg tablet Nov-81 Acipimox Capsules 250mg. 26.11.2009 Acitretin 09-09-2005 Aclarubicin Hydrochloride Injection March-1988 Acotiamide Hydrochloride Bulk & Tablet 100mg 06.07.2016 Acrivastine Capsules 8mg 26.09.11 Actarit 100mg Tablets 22.07.08 Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried Aluminium Hydroxide 250 28-05-2010 mg + Sorbitol (70%)1.25 gm /5ml Solution Activated Dimethicone 50mg + Magnesium Hydroxide 250mg+ Dried Aluminium Hydroxide250 mg 28-05-2010 + Sorbitol (70%)1.25 gm /5ml Solution

Activated Methylpolysiloxane 125mg + Magnesium Hydroxide 100mg + Aluminium Hydroxide Jun-73 5gm per 5ml solution Acyclovir 200mg Tablet October-1987 Acyclovir 3% Ophthalmic Ointment & 400mg/5ml Suspension(30.07.91) October-1987 Acyclovir 5% Cream/Ointment October-1987 Acyclovir 50g + Hydrocortisone 10mg Cream 30.08.11 Acyclovir 50g + Hydrocortisone 10mg 30.08.11 Cream

PHARMADOCX CONSULTANT 6 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Acyclovir SR Tablet 1200 mg 11.09.10 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel 24.10.08 Adapalene 0.1% + Benzoyl Peroxide 2.5% gel 24.10.08 Adapalene1mg +Clindamycin Phosphate eq. to Clindamycin 10mg per gram Gel 01.05.2003 Adefovir Dipivoxil 04-03-2004 Ademetionine enteric coated Tablets 01.09.10 ..200mg/400mg Adenosine 6mg/2ml ampoule Injection 8-7-1997 Adenosylcobalamin 15mcg + Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate 21.03.11 USP Eq. to Elemental Zinc 22.5mg tablet Adenosylcobalamin 15mcg + Ferrous 21.03.11 Ascorbate 100mg + Folic Acid IP 1.5mg + Zinc Sulphate USP Eq. to Elemental Zinc 22.5mg tablet Monosemicarbazone (Bulk) March-1969 Aeterolane Malate (150mg) + Piperaquine Phosphate (750mg) Tablet FDC of 11.10.2013 Afatinib Tablets 20mg/30mg/40mg/50mg (Free base) corresponding to Afatinibdimaleate 27.09.2016 29.56mg/44.34mg/59.12mg/73 .9mg (Additional Indication) Agomelatine Tablets 25mg 10.09.2012 Akiskiren Hemifumarate eq. to Aliskiren 150mg/150mg/300mg/300mg +Amlodipine Besilate IP eq. 12.10.11 to Amlodipine 5mg/10mg/5mg/10mg Tablets Akiskiren Hemifumarate eq. to Aliskiren 12.10.11 150mg/150mg/300mg/300mg +Amlodipine Besilate IP eq. to Amlodipine 5mg/10mg/5mg/10mg Tablets Albendazole 2.5% w/v & 10% w/v Suspension October-1979 Albendazole 200mg/5ml Suspension February-1986 Albendazole 400 mg + Ivermectin 6 mg tablet 25.04.2009 Albendazole 400 mg + Ivermectin 6 mg tablet 25.04.2009 Albendazole Tablet 200mg February-1986 Albendazole tablet 400mg and suspension 28-11-2011 400mg/10ml (Additional Indication) Alcaftadine Eye Drops 0.25% w/v & Bulk 21.11.2016 Alclometasone Dipropionate 0.05% Cream/Ointment July-1987 Alectinib 150mg Capsules (Alectinib Hydrochloride) 23.01.17 Alendronate 70mg + Colealciferol 140mcg (5600 IU) Tablets 10.11.2009 Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U 1-2-2006 Vit.D) Tablet Alendronate Sodium (equiv. to Alendronic acid 70mg) + Cholecalciferol 70mcg (equiv. to 2800 I.U 02-01-2006 Vit.D) Tablet Alendronate Sodium 10mg (as alendronic acid) Uncoated Tablet 18-9-1997 Alendronate Sodium 5mg 6-3-2000 Alenolol S(-) 25mg+Hydrochlorthiazide 12.5mg tablets 16.01.2004 Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet 14.06.07 Alfuzocin Hcl. ER (10mg) + Dutasteride 0.5mg tablet 14.06.07 E.R. Tablets (10 mg) 14-05-2004 Aliskiren 150/160mg + Valsartan 300/320mg tablets 19-01-2010 Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets 08.05.08 Aliskiren 150/150/300/300mg + HCTZ 12.5/25/12.5/25mg tablets 08.05.08 Aliskiren 150/160mg + Valsartan 300/320mg tablets 19-01-2010 Aliskiren Tablet 150mg/300mg 08.06.07 Alkyl dimethyl benzoyl ammonium chloride 5%+ Nonyl phenolethoxide 6%+Inert ingredient 89% 23.08.1999 Allergen Extracts January-1979 Allergens September-1978 Allopurinol 100mg Tablet March-1969 Allyloestrenol 5mg Tablet January-1964 Almotriptan Tablet 6.25mg/12.5mg 05.10.12

PHARMADOCX CONSULTANT 7 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Aloe Ext. April-1965 Alogliptin Tablet 6.25 mg/12.5 mg/ 25 mg 27 08 14 Alpha chymotrypsin 60mg + Ethyl nicotinate 200 mg per 20 gm ointment Sep-71 Alpha chloropyridazine sodium 10gm + trimethoprim 2gm per 100gm powder for vetarnary use May-90 Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine 10.08.11 Hydrochloride 3mg + Vitamin D3 1000 IU Tablets Alpha Lipoic acid 100mg + Folic acid 1.5mg + Methylcobalamin 1500mcg + Pyridoxine 10.08.11 Hydrochloride 3mg + Vitamin D3 1000 IU Tablets Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 03.01.11 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. to Chromuim 200mcg Capsule Alpha Lipoic Acid USP 100mg + Methylcobalamin 1500mcg + Vitamin B6 IP 3mg + Folic Acid IP 03.01.11 1.5mg + Benfotiamine 50mg + Biotin USP 5mg + Chromium Picolinate USP Eq. to Chromuim 200mcg Capsule Alphachymotrypsin November-1967 Alphachymotrypsin - 25chg Units Tablet July-1975 Alphachymotrypsin 5mg/vial Injection August-1973 Alprazolam 0.25mg/0.5mg/1mg Tablet June-1988 Alprazolam 1.5mg SR Tablet September-1997 Alprazolam Dispersible Tab. 0.125mg/0.25mg/0.50mg 20-09-06 Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet 9-8-2006 Alprazolam SR 0.25mg + Sertraline (As Hcl) 25mg/50mg tablet 08-09-2006 Alprazolam sublingual tablets 0.5mg/1mg (New dosage form) 27-10-2011 Alprostadil Injection 09.05.2002 Altretamine 50mg Capsule 10-3-1995 Aluminium Salicylate February-1965 Aluminium sodium silicate + Magnesium hydroxide + Methypolysiloxane Tablet Jun-67 Amantadine Hydrochloride December-1972 Ambodryl 100mg + Aspirin 190mg + Phenacetin 65mg + Caffiene 15mg + HCl Nov-70 10mg + Aluminium hydroxide gel 100mg tablet Ambrisentan film coated Tablets 5 mg / 10mg 24-05-2010 Ambroxol 30mg + Gnaiphenesin 100mg + Menthol 1mg + Psendoephedrine 60mg per 5ml syrup 29.10.1999 Ambroxol Hcl 30mg + Guaiphenesin 200mg tablet 10.09.2001 Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. 11-10-2005 Ambroxol (as Hcl) S.R.B7.5mg + Doxycyline Hcl 100mg tablet 23.08.2001 Ambroxol + loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml) 18.08.08 Ambroxol + Loratadine + Guaifenesin Syrup (30mg + 5mg + 50mg per 5ml) 18.08.08 Ambroxol 30 mg + 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup 27.10.2009 (additional strength) Ambroxol 30 mg+ Terbutaline 27.10.2009 2.5 mg + Guaiphenesin 100mg + Menthol 2.5 mg per 5 ml syrup Ambroxol 30mg + Levo 1mg+ Guiphenesin 50mg /5ml syrup 19.03.09 Ambroxol 30mg + Levo salbutamol 1mg+Guiphenesin 50mg /5ml syrup 19.03.09 Ambroxol HCl 15mg + Guaiphenesin 100mg + Ethanol 95% eq to Ethanol 5% v/v per 5 ml oral 18.08.2000 liquid Ambroxol HCl 15mg+ Salbulamol 1mg + Guaiphenesin 50mg+ Methol 1mg per 5 ml syrup 16.06.1999 Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup 26.03.08 Ambroxol HCl 30mg + Guaiphenesin 100mg + Terbutaline sulphate 2.5mg per 10ml Syrup 26.03.08 Ambroxol Hcl 30mg Ambroxol Hcl 30mg/5ml Liquid 1-12-1995 Ambroxol Hcl 7.5mg/ml Drops Ambroxol HCl 75mg (S.R) + Desloratadine 5mg Capsule. 10-11-2005 Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 26.03.08 ml of syrup Ambroxol HCl. 15mg + Guiphenesin 50mg + Terbutalin sulphate 1.25mg + Menthol 2.5mg per 5 26.03.08 ml of syrup Ambroxol+Pseudoephedmine+Chlorpheniramin e maleats tabs/suspension/syrup 26.02.1998 Amifostine 500mg per vial Sterile Lyophilised Powder For Injection 21-3-1996

PHARMADOCX CONSULTANT 8 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Amifostine Injection 6-11-2000 Amikacin Sulphate 100mg/250mg/500mg per vial Injection June-1986 Amiloride 5mg / 5mg + Frusemide 20mg/40mg tablet Jun-89 Amiloride 5mg + HCTZ 50mg Tablet Sep-79 Amineptine Hcl 100mg Tablet January-1988 Amino acid 5% w/v IV Infusion with & without electrolytes 07.02.2001 Amino Acid, Glucose Parentral Solution (Solution for intravenous infusion) 08.07.08 Aminoglutethimide Tablets August-1985 Aminomix -2 Infusion Solution Solution A 500ml & 7 Solution B 500ml 04.07.2000 CR 225/350mg 21.03.07 Amiodarone Hcl 100mg/200mg Tablet & Amiodarone Hcl 150mg/3ml ampoule Injection April-1990 Amiodarone Injection (additional Indication). 05-10-2007. Amisulpiride 300mg tablets (Additional Strength) 20.03.08 Amisulpiride SR Tablet 100 mg 27.11.2009 Amisulpiride Tablet (50/100/200mg) 1-8-2006 Amisulpride 400mg tablet (additional strength) 1-12-2006 Amisulpride S.R.Bilayered tablet 200/400mg 03.11.08 2%w/v pour on solution 12-06-2010 Amitraz BP 50mg/125mg per ml Emulsifiable Concentrate (For Veterinary) 6-8-1996 Hydrochloride 10/25mg Tablet & 10mg/cc August-1962 Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream. 13.10.10 Amitriptyline Hydrochloride IP 4%w/w + Ketamine HCL eq. to Ketamine 2% w/w per gm cream. 13.10.10 Amitryptylline Hydrochloride 25mg Tablet October-1978 Oral PAste (5%) 16.05.07 Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg) Tablet FDC of 20-10-2004 Amlodipine (5mg/5mg) + (2.5mg/5mg) tablet FDC of 21-07-2005 Amlodipine 2.5/5/5mg + 25/50/25mg Capsules 16.07.2008 Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/320mg 24.11.2009 + Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25mg Tablets Amlodipine Besylate 5mg/10mg/2.5mg Tablet 19-5-1993 Amlodipine (5 mg) + Ramipril (2.5 mg) tablet 24-09-2004 Amlodipine (5mg) + Bisoprolol (2.5mg) FDC of 21-07-2005 Amlodipine (5mg) + (5mg) tablet (addl. Strength). 06-09-2007. Amlodipine (5mg) + Nebivolol (5mg) tablet (addl. Strength). 06-09-2007. Amlodipine (5mg/10 mg) + Atorvastatin (10/20/40 mg) FDC of 20-10-2004 Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet 21.02.07 Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg 08-12-2005 Amlodipine (as besylate ) 5mg + Losartan Pot. 50mg tablet. 12-08-2005 Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength) 07.05.07 Amlodipine (As besylate) 10mg + Perindopril 8mg tablets (additional strength) tablet 07.05.07 Amlodipine (as besylate)- 2.5mg/5mg + Benazepril-10mg/20mg capsule 22.03.2002 Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. 5-6-2006 Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (additional strength)tablets 14.02.07 Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) 30-11-2005 Amlodipine (as besylate) 5mg + Bisoprolol 5mg Tablet (Addl. Strength) 30-11-2005 Amlodipine (as besylate) 5mg + HCTZ 12.5mg Tablet 24-04-2006 Amlodipine (As besylate) 5mg + Metoprolol (As succinate) ER 25mg (additional strength) 14.02.07 Amlodipine (as besylate) 5mg + Metoprolol Succinate equivalent to Metoprolol Tartrate 50mg. 06-05-2006 Amlodipine (as besylate) 5mg/2.5mg + HCTZ 12.5mg/12.5mg Tablet 24-04-2006 Amlodipine (As besylate) 5mg/5mg/10mg + valsartan 80mg/160mg/160mg tablet 21.02.07 Amlodipine (As besylate)5mg/10mg + Perindopril 4mg tablet 23.02.07 Amlodipine (As besylate)5mg/10mg + Perindopril 4mg tablet 23.02.07 Amlodipine (S (-) 2.5mg/5mg+ 50mg/50mg tablet 25.03.2003 Amlodipine + Metoprolol (2.5mg/5 mg + 25mg/50mg (ER) Tablets(additional strength) 10.11.08 Amlodipine + Metoprolol (2.5/5 mg + 25/50mg (ER))Tablets 10.11.08 Amlodipine 10mg/10mg + Telmisartan 40mg/80mg Tablets 31.05.11 Amlodipine 10mg/10mg + Telmisartan 40mg/80mg Tablets (Additional Strength) 31.05.11

PHARMADOCX CONSULTANT 9 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Amlodipine 25mg + Metoprolol 25mg (additional lower strength) tablet 11-01-2006 Amlodipine 25mg + Metoprolol 25mg (additional lower strength) 1-11-2006 Amlodipine 5 mg + Ramipril 2.5mg capsule 04.10.2004 Amlodipine 5mg/10mg/5mg/10mg/10mg + Valsartan 160mg/160mg/160mg/160mg/32 0mg + 24.11.2009 Hydrochlorothizide 12.5mg/12.5mg/25mg/25mg/25 mg Tablets Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet 21.09.10 Amlodipine 5mg/2.5mg + Valsartan 320mg/80mg + HCTZ 12.5mg/12.5mg tablet (additional 21.09.10 strength) Amlodipine 5mg/2.5mg+Enalapril Maleate 5mg/2.5mg tablets 16.11.1995 Amlodipine besilate IP Eq. to Amlodipine 10mg + Indapamide SR 1.5 mg Tablet (Additional 02.01.2013 Strength) Amlodipine besilate IP Eq. to Amlodipine 10mg + Indapamide SR 1.5 mg Tablet (Additional 02.01.2013 Strength) Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP 8mg Tablets. 20.12.11 (Additional Strength). Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet 05.01.11 Amlodipine Besilate IP Eq. to Amlodipine 5mg + Indapamide USP SR 1.5mg Tablet 05.01.11 Amlodipine Besilate IP eq. to Amlodipine 5mg + Perindopril Erbumine BP 8mg Tablets. 20.12.11 (Additional Strength). Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg + Olmesartan Medoxomil 23.11.11 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP 25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet Amlodipine Besilate IP eq.to Amlodipine 10mg/5mg/5mg/5mg/2.5mg + Olmesartan 23.11.11 Medoxomil 40mg/40mg/20mg/5mg/5mg + Hydrochlorothiazide IP 25mg/12.5mg/12.5mg/12.5mg/12.5mg Tablet Amlodipine besilate IP S(-) Eq to S(-) Amlodipine 5mg / 2.5mg + Hydrochlorothiazide IP 18.10.13 25mg/12.5mg +Olmesartan Medoxomil 40 mg /40 mg Tablet Amlodipine besilate S (-) Eq. to S (-) Amlodipine 2.5mg/5mg + HCTZ 12.5mg/12.5mg tablet 15.04.2004 Amlodipine Besylate S (-) 16.08.2002 Amlodipine Besylate BP Eq. to Amlodpine 5mg + Losartan Potassium USP 25mg/50mg film 14.05.2008 coated tablets Amlodipine besylate Eq. to Amlodipine 5mg + Lisinoril eq. to Lisinopril anhydrous 5mg tablet 27.03.1997 Amlodipine besylate eq. to Amlodipine 5mg+ Atenolol 50mg Besylate uncoated tablets 16.05.1996 Amlodipine Besylate eq.to Amlodipine 5mg + Atorvastatin calcium eq. to Atorvastatin 10mg each 11.02.2004 tablets Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg + Telmisartan 80mg/40mg/20mg + 12.10.10 HCTZ 25mg/12.5mg/12.5mg tablet Amlodipine Besylate IP Eq. to Amlodipine 10mg/5mg/2.5mg 12.10.10 +Telmisartan 80mg/40mg/20mg + HCTZ 25mg/12.5mg/12.5mg tablet Amlodipine Besylate S(-) eq. to S(-) Amlodipine-2.5mg+Atorvastatin cal eq. to Atorvastatin 10mg 10.02.2004 tablet Amlodipine Orally Disintegrating Strips 2.5mg/5mg/10mg 07.01.2016 Amlodipine S(-) 2.5mg/5mg + Atenolol 8mg/8mg Tablet 09.7.2003 Amlodipine S(-) 2.5mg/5mg + 22.09.11 Clopidogrel 75mg/75mg Tablets Amlodipine S(-) 5mg+Atenolol 50mg tablet 09.07.2003 Amlodipine S(-) 2.5mg + Nebivolol 5mg Tablets 13.09.2004 Amlodipine S(-) 2.5mg + Ramipril 2.5mg Tablet 02.10.2003 Amlodipine S(-) -2.5mg/2.5mg +Atenolol 25/50mg tablet 17.10.2002 Amlodipine S(-) -2.5mg/2.5mg +Losartan Potasium 25mg/50mg tablet 17.10.2002 Amlodipine S(-) 2.5mg/5mg + Clopidogrel 75mg/75mg Tablets 22.09.11 Amlodipine S(-) 2.5mg+Lisinopril 5mg tablet 10.03.2003 Amlodipine S(-) 5.0mg +Losartan Potasium 50mg tablet 17.04.2003 Amlodipine Tablets 5mg/10mg (additional indication) 02.05.2009 Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength) 03-10-2010 Amlodipine5mg + Ramipril10mg/5mg Tablets (additional strength) 10-03-2010 Ammoidin + Amidine Jul-67

PHARMADOCX CONSULTANT 10 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Ammonium Lactate Cream 12% w/w 03.12.2010 Ammosidine Sulphate 500mg/Vial June-1976 Amorolfine 25-11-2003 Amoscanate 250mg Tablet November-1985 25mg/50mg/100mg/150mg Tablet November-1985 Amoxicillin 125mg + Carbocistine 75mg per 5ml syrup Apr-91 Amoxicillin 250/500mg + Carbocistine 150mg/150mg capsule Apr-91 Amoxicillin Trihydrate IP eq to Amoxicillin 80 mg + Potassium Clavulanate IP eq to 14.10.14 Clavulanic Acid 11.4 mg (additional Strength) Each 1 ml of the constituted suspension contains:

Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores 31.01.08 Amoxicillin 250mg + Lacto- Bacillus 1.7 billion Spores capsule 31.01.08 Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores 30.01.08 Amoxicillin 250mg/125mg + Cloxacillin 250mg/125mg + Lactic Acid Bacillus 1.7 Billion spores 30.01.08 Amoxicillin trihydrate (Oral Suspension: 09.12.03 Each 5ml of reconstituted suspension contains: )USP e.q. to Amoxicillin 400 mg Caluvulanate Potassium e.q. to Clavulanic acid 57 mg Dispersible Tablet: Each dispersible tablet contains: Amoxicillin trihydrate IP e.q. to Amoxicillin 400 mg Caluvulanate Potassium e.q. to Clavulanic acid 57 mg Amoxycillin December-1978 Amoxycillin 250mg + Clavulanic acid 150mg dispersible tablet 23.12.1999 Amoxycillin 875mg + Clavulanic Acid 125mg tablets 27.01.1999 Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsules 30.01.08 Amoxycillin 250mg + Dicloxacillin 250mg + Lactobacillus 2.5 million spores capsules 29.01.2008 Amoxycillin 500mg + Potassium Clavulanate 100mg injection 03.10.1994 Amoxycillin (Present as amoxicillin trihydrate IP) 500mg + Clavulanic Acid (Present as potassium 06.01.1995 clavulanate USP) 125mg film coated tablets Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC Tablets 25.11.08 Amoxycillin + Clavulanic acid(1gm + 62.5mg ) FC Tablets 25.11.08 Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet 8-6-2006 Amoxycillin 1000mg + Clavulanate Potassium 62.5mg E.R tablet 06-08-2006 Amoxycillin 125mg/1.25ml Paediatric Suspension January-1979 Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules) 31.01.08 Amoxycillin 125mg/250mg/500mg + Lactobacillus 1.66 billion Spores (Capsules) 31.01.08 Amoxycillin 125mg/5ml & 250mg/5ml Syrup January-1979 Amoxycillin 250mg + Cloxacillin 250mg + Lactobacillus 2 billion spores capsules 30.01.08 Amoxycillin 250mg + Dicloxacillin 250mg cap. 28-08-06 Amoxycillin 250mg + Dicloxacillin 250mg cap. 28-08-06 Amoxycillin 250mg/500mg Capsule January-1979 Amoxycillin 250mg/500mg/1gm per Vial Injection June-1979 Amoxycillin 3H2O 200mg/400mg Dispersible Tablet 26-5-2000 Amoxycillin 500mg/1gm + Clavulanic acid 100mg/200mg each vial Injection May-87 Amoxycillin as trihydrate 125mg + Clavulanic Acid 31.25mg as potassium salt suspensionEach 5 ml 07.08.1990 reconstituted syrup contains:

Amoxycillin Oral Suspension 200/400 mg per 5ml 09-08-10 Amoxycillin Trihydrate 125mg Dispersible Tablet March-1980 Amoxycillin trihydrate 250mg+Potassium Clavulanic eq. to Clavulanic acid 125mg each tablet Feb-87 Amoxycillin Trihydrate 750mg Bolus (For Veterinary) 16-10-1996 Amoxycillin trihydrate IP e.q. to Amoxycillin 200 mg + Potassium caluvulanate e.q. to Clavulanic 13.12.99 acid 28.5 mg Each uncoated dispersible tablet contains:

PHARMADOCX CONSULTANT 11 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Amoxycillin trihydrate IP e.q. to Amoxycillin 200 mg Old drug Caluvulanate Potassium e.q. to Clavulanic acid 28.5 mg Each 5ml of reconstituted suspension contains:

Amoxycillin trihydrate IP e.q. to anhydrous Amoxycillin 250 mg/125 mg 28.01.91 Caluvulanate Potassium e.q. to Clavulanic acid 62.5 mg/31.25mg Each uncoated dispersible tablet contains: Amphotericin B (USP) 5mg/ml per 10ml/20ml Lipid Complex Injection 12-7-2000 Amphotericin B Emulsion 5mg/ml (Addl. Indication) 18.7.2009 Amphotericin B Lipid suspension 50mg/ vial (Addl. Strength) 12.12.08 Amphotericin B Lipid suspension injection (25mg/vial) with lipid suspension 03.06.08 Ampicillin August-1965 Ampicillin 3.5gm+ Probenecid 1.0gm single vial Feb-83 Ampicillin Sodium 0.25/0.5gm + Sulbactum Sodium 1gm/2gm per vial Injection 06.05.1992 Ampicillin 250mg + Dicloxacillin 250mg tablet 13-12-06 Ampicillin 250mg + Dicloxacillin 250mg tablet 13-12-06 Ampicillin Sodium 0.5gm + Sulbactum Sodium 1gm per vial Injection Sep-91 Amprolium HCl IP 16.67% w/w Sulfaquinoxaline IP 16.67% w/w Powder 03.02.2017 (veterinary product) Amrinone Lactate 5mg/ml Injection May-1988 Amsacrine Injection 26-2-1992 Amtolmetin Guacil tablets 600mg 07.03.08 Amylase + Cellulose + Protinase + Pencreatic enzyme + Lipase Capsule Dec-71 Amylobarbitone + Trifluperazine Dihydrochloride Capsule Feb-67 Anastrazole 10.02.2003 Anidulafungin Injection (Lyophilized powder) 50mg/100mg per vial 23.02.09 Anti-Rabies Vaccine (Killed virus) (For Veterinary) March-1989 Anti-Tetanus activity 500IU + Anti-Diptheria activity 1000IU Immunoglobulin (Human) Injection October-1977 Apixaban Tablets 2.5/5mg (additional Indication) 29.05.15 Apixaban Tablets 2.5mg 03.08.2012 Apixaban tablets 2.5mg/5mg (Additional Strength & Additional Indication) 16.05.2014 Apomorphine HCL-2mg/3mg Sublingual tablet. 12.11.07 Ophthalmic Sol. 15.03.2002 Apramycin Sulphate 50gm in each 100gm. 22-7-1997 Aprepitant 40mg capsules (additional strength) 24.04.07 Aprepitant cap (80mg/125mg) 30-08-06 Aprotinin November-1973 Aprotinin 100,000 KIU/5ml & 200,000 KIU/10ml Injection January-1974 Aremther 20mg + Lumefantrine 120mg tablet 26.12.2002 (as Tartrate ) 15mcg / 2ml Inhalation Solution 29.05.09 Argatroban Hydrate Bulk & Injection 250 mg/2.5 ml 30.05.2017 Aripiprazole 11.06.2003 Armodafinil uncoated tablet....50/150/250mg 23-04-2010 Arteether 150mg per ampoule i.m Injection 14-1-1997 Arteether injection 150mg/mL 03-12-2010 Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength) 05.08.08 Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup 30.09.08 Artemether 60mg +Lumefantrine 360mg (additional Strength) uncoated Tablets 29.07.13 Artemether + Lumefantrine (80mg + 480mg/5ml) Dry syrup 30.09.08 Artemether + Lumefantrine Dispersible tablet (40/80mg + 240/480mg ) (Additional Strength) 05.08.08 Artemether 20mg + Lumefantrine 120mg Dispersible tablet (Additional Strength) 08.02.2010 Artemether 20mg + Lumefantrine 120mg Syrup 05.01.2011 Artemether 40mg 21.09.2010 Lumefantrine 240mg (Additional strength) Each 5ml reconstituted oral suspension contains:

PHARMADOCX CONSULTANT 12 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Artemether 40mg 21.09.2010 Lumefantrine 240mg (Additional strength) Each 5ml reconstituted oral suspension contains:

Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength) 24.06.08 Artemether 40mg/80mg + Lumefantrine 240mg/480mg tablets (additional Strength) 24.06.08 Artemether 80mg per ampoule Injection Artemether 40mg Capsule 2-8-1996 Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet 19.10.11 Arterolane Maleate 150mg + Piperaquine Phosphate 750mg Tablet 19.10.11 Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets 01.09.2009 Artesunate (25/50/100mg) + Amodiaquine (67.5 mg/135/270mg) bilayerd Tablets 01.09.2009 artesunate (3 tablets of )100mg + 3 tablets of Artesuante 50mg & 2 tablets of FDC of 28-05-2010 Pyrimethamine 25mg + Sulphadoxine 500mg combipack artesunate 100mg (3 tablets of ) + 3 tablets of Artesuante 50mg & 2 tablets of FDC of 28-05-2010 Pyrimethamine 25mg + Sulphadoxine 500mg combipack artesunate 150mg (one strip of 3 uncoated tablets of )& one strip of 2 uncoated tablets of FDC of 04-05-2010 Sulphadoxine IP 500mg + Pyrimethamine IP 25mg artesunate 150mg(one strip of 3 uncoated tablets of ) & one strip of 2 uncoated tablets of FDC of 05-04-2010 Sulphadoxine IP 500mg + Pyrimethamine IP 25mg Artesunate 150mg/200mg + Sulphadoxine 500mg/750mg + Pyrimethamine 25/37.5mg Combipack 25.07.2006 Artesunate 50mg Tablet 7-10-1996 Artesunate 60mg per ampoule Injection 2-9-1996 Artesunate injection. Each combipack contains: "Artesunate for injection 120mg ( Each vial 13.11.13 contains Artesunate IP 120mg), Sodium bicarbonate injection IP 5%w/v (Each 2ml ampoule contains: Sodium Bicarbonate IP 5% w/v), Sodium chloride Injection IP 0.9% w/v (Each 10ml ampoule contains: Sodium chloride IP 0.9% w/v)" (Additional strength) Artesunate injection. Each combipack contains: "Artesunate for injection 120mg ( Each vial 13.11.2013 contains Artesunate IP 120mg), Sodium bicarbonate injection IP 5%w/v (Each 2ml ampoule contains: Sodium Bicarbonate IP 5% w/v), Sodium chloride Injection IP 0.9% w/v (Each 10ml ampoule contains: Sodium chloride IP 0.9% w/v)" Artesunate powder for injection 60mg/vial alongwith 6ml ampoule of phosphate buffer solution (pH 02.07.2014 8.0;0.30M) Articaine Hydrochloride August-1986 Ascerbine December-1970 Maleate Sublingual Tablets 5mg/10mg 07.04.11 Asiaticoside November-1976 Aspirin 150mg + Clopidogrel 300mg Tablet (additional strength) 26.11.2002 Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Indication) 22-06-2006 Aspirin 25mg+ Dipyridamole BP 200mg (ER) capsule 27.02.2003 Aspirin (EC Tablets) 75mg/75mg/150mg +Rosuvastatin (Granules) 5mg/10mg/10mg Capsules 30.03.11 Aspirin (ECTablets) 75mg/75mg/150mg + Rosuvastatin (Granules) 5mg/10mg/10mg Capsules 30.03.11 Aspirin 150mg + Clopidogrel (as bisulphate) 300mg tablet (addl. Strength) 22-06-2006 Aspirin 150mg + ISMN 60mg SR Tablets 07.11.2002 Aspirin 325mg/500mg Delayed Release Tablet 6-9-1993 Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet 10-8-2006 Aspirin 75mg / 150mg + Glycine 37.5mg/75mg tablet 08-10-2006 Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg + Atenolol 25mg/50mg Tablets 06-01-2010 Aspirin 75mg + Simvastatin 10mg/20mg + Lisinopril 5mg/10mg 01-06-2010 + Atenolol 25mg/50mg Tablets Aspirin 75mg/75mg + Clopidogrel 150mg/150mg Tablet 26.11.2002 Aspirin Bolus (Vet.) 6gm/bolus) 21-11-2005 Aspirin DL Lysine 900mg per vial Injection April-1986 Astemizole 5mg/5ml Suspension August-1988 Atazanavir + Ritonavir (300mg + 100mg) FC Tablets 04.11.08 Atazanavir (100/150/200mg) 24-04-2006

PHARMADOCX CONSULTANT 13 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Atazanavir + Ritonavir (300mg + 100mg) FC Tablets 04.11.08 Atazanavir 150mg + Ritonavir 50mg capsules 12-12-2006 Atazanavir 150mg + Ritonavir 50mg capsules 12-12-2006 Atazanavir 300mg capsules (Additional strength) 08.01.08 Atenolol 25/50mg + Chlorthalidone 6.25 mg tablets 31.01.2008 Atenolol BP 50mg + Nifedipine SR 20mg capsule Jan-90 Atenolol (25mg, 50mg) + HCTZ (12.5mg) 13-01-2005 Atenolol (25mg, 50mg) + HCTZ (12.5mg, 12.5 mg ) Tablet 13-01-2005 Atenolol (Bulk) January-1986 Atenolol 25mg/50mg + Indapamide SR 1.5mg 21.05.07 Atenolol 25mg/50mg + Indapamide SR 1.5mg tablet 21.05.07 Atenolol 50mg + HCTZ 25mg (addl. Strength) 3-2-2006 Atenolol 50mg + HCTZ 25mg (addl. Strength) 02-03-2006 Atenolol 50mg/100mg Tablet September-1985 Atomoxetine (as HCl) Sachet (10/18/25/40mg) 15-12-2005 Atomoxetine 60mg capsule (Addl. Strength) 27-02-2006 Atomoxetine HCl (10,18, 25 & 40mg ) capsule 09-11-2004 Atorvastatin (10 mg/20 mg) + Ezetimibe (10 mg) Table FDC of 13-08-2004 Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication) 25.01.08 Atorvastatin 5mg + Fenofibrate 160mg (additional strength)tablets 12-01-2006 Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule FDC of 26-07-2005 Atorvastatin (10mg) + Niacin (375mg/500mg E.R) Capsule FDC of 26-07-2005 Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength). 30-07-2007. Atorvastatin (40mg) + Ezetimibe (10mg) Tablet (addl. Strength). 30-07-2007. Atorvastatin + Metformin(10mg + 500mg SR) Tablets 04.12.08 Atorvastatin + Metformin(10mg + 500mg SR) Tablets 04.12.08 Atorvastatin 10mg + Aspirin 75/150mg Capsules 18.01.08 Atorvastatin 10mg + Aspirin 75/150mg Capsules 18.01.08 Atorvastatin 10mg + Fenofibrate 80mg tablet (Additional Indication) 25.01.08 Atorvastatin 10mg/20mg + Ezetimibe10mg/10mg tablet 08.11.2004 Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules (additional strength) 17-03-2010 Atorvastatin 20mg + Ramipril 2.5mg/5mg Capsules 17-03-2010 Atorvastatin 5/10/5mg + Telmisartan 20/20/40 mg 22.05.2008 Atorvastatin 5mg + Fenofibrate 160mg (additional strength) 1-12-2006 Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. strength) tablet 30-10-2007. Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet 15-10-2007. Atorvastatin Calcium (10mg ) + Ramipril (2.5mg/5mg) tablet 15-10-2007. Atorvastatin Calcium (10mg) + Fenofibrate (145mg) (addl. strength) 30-10-2007. Atorvastatin Calcium (10mg) 22-12-2004 + Finofibrate (160mg) tablet FDC of Atorvastatin Calcium 10mg/20mg/40mg Film Coated Tablet 17-9-1999 Atorvastatin calcium 5mg/10mg/20mg/40mg/80mg (Additional Dosage Form) 20-04-2011 Atorvastatin Calcium 80mg tablets (Additional Strength) 25.02.08 Atorvastatin Calcium eq. Atorvastatin 10 mg + Fenofibrate (micronised) 160mg film coated tablets 24.12.2004 Atorvastatin Calcium IP Eq. to Atorvastatin 5mg + Fenofibrate BP 145mg film coated tablet 29.04.2010 (additional strengths) Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 05-04-2010 25mg Capsules Atorvastatin10mg + Ramipril 5mg + Aspirin (EC pellets) 75mg/150mg + Metoprolol (ER tablets) 04-05-2010 25mg Capsules Atorvastin 10mg/20mg+ Ezatimib 10mg/10mg tablet 13.08.2004 Atorvaststin10mg + Nicotinic Acid 375mg/500mg (ER) Tablets 28.07.2005 Atosiban Acetate Injection 6.75mg/0.9ml and Bulk 16.09.15 Atricurium Dibesylate Injection January-1986 Atropine Sulphate 0.06mg + Hyoscyamine sulphate 0.30mg + Scopolamine hydrobromide 0.035mg Dec-69 + Phenobarbatal 64.8mg capsule Auranofin 3mg Capsule December-1987

PHARMADOCX CONSULTANT 14 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Autolysate of β-subtilis+β- megatherium Jul-75 Axitinib Tablet 1mg/5mg 18.09.14 Azabiperidol (Bulk) September-1981 Azacitidine 23 07 14 Azacitidine 100 mg / vial 29 04 14 Azacitidine for injection 100 mg 07.03.2017 Azacitidine Lyophilized powder for Injection 100mg/vial 04.08.2016 (Intravenous or Subcutaneous) Azatadine Maleate 1mg Tablet November-1980 Azathioprine 25mg Tablets 19.12.08 Azathioprine 50mg/100mg Tablet July-1969 Azelaic Acid 08-07-2003 Azelaic acid Cream (15%) 23-02-2005 Azelastine 0.5mg/ml Eye Drops 5-5-2000 Azelastine Hcl 0.01gm/10ml Nasal Spray 15-7-1997 Azilsartan Medoxomil Bulk & 40mg/80mg Tablets 09.12.2016 Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops 21.10.08 Azithromycin + Dexamethasone (10mg + 1mg) Eye Drops 21.10.08 Azithromycin 500mg + Ambroxol S.R (75mg) Tablet. 05-07-2007. Azithromycin 500mg + Ambroxol S.R (75mg) Tablet. 05-07-2007. Azithromycin Dihydrate 250mg Capsule Azithromycin 200mg/50mg per 5ml Suspension 13-5-1994 Azithromycin eye drops 1% 06.06.07 Azithromycin SR Granules for oral suspension 2000mg 26.6.2009 Azithromycin SR Granules for Oral Suspension 1gm (Addl. Strength) 05-04-2010 Azithromycin Tablet 250mg/500mg 6.3.13 Aztemizole 10 mg Tablet February-1988 Aztreonam 01.11.2002 b -arteether Injection (150 mg/2 ml) 01-09-2004 Bacampicillin Hcl 400mg Tablet October-1985 Bacillocid Special 20-5-1992 Bacillus Calmette and Geurin (Immucyst, BCG therapeutics) 27mg dry weight per Vaccine 22-6-1992 Bacillus calusii spores suspension (2billion/5ml vial) 28-01-2005 Bacillus Clausii Spores (2 Billion) Capsules (additional dosage form) 23.07.08 Baclofen E.R capsule (30mg) 1-8-2006 Baclofen ER (GRS) Capsule 45mg/60mg (additional strength) 22.02.07 Baclofen ER Capsule 10 mg/50 mg. (Additional Strength) 17.02.11 Baclofen USP 10mg/25mg Tablet 29-9-1995 Balanced salt intra ocular irrigating solution enriched with glutathione Dextrose, bicarbonate 26-04-2005 Balofloxacin Tablet 100mg 22.12.2009 Balsalezide Disodium 12.11.2002 Hcl 1mg/ml Oral Suspension 27-9-2000 Bambuterol Hcl BP 10mg/20mg Uncoated Tablet iBambuterol Hcl 1mg/ml Oral Suspension 13-12-1999 Banoxinate Hcl Ophthalmic Solution 24-11-1992 Basiliximab Injection 28-5-1999 Beclomethasone Dipropionate 0.025% + Chinoform 3% Ointment & Cream Apr-74 Beclomethasone Dipropionate 0.025% + Neomycin Sulphate 0.5% Ointment & Cream Apr-74 Beclomethasone Dipropionate 0.025% Cream & Ointment April-1974 Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg cream 30.01.2008 Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream 30.01.08 Beclomethasone Dipropionate 0.25mg + Econazole 10mg + Neomycin 5mg per gm of Cream 30.01.08 Beclomethasone Dipropionate 50mcg MDI December-1975 Beclomethasone Dipropionate 50mcg/100mcg/250mcg Inhaler 21-12-2000 Beclomethasone Dipropionate B.P. February-1973 Beclomethasone Dipropionate IP 0.025% w/w + Neomycin sulphate IP 0.5% w/w cream 15.09.10 Beclomethasone Dipropionate IP 0.025% w/w 15.09.10 + Neomycin sulphate IP 0.5% w/w cream

PHARMADOCX CONSULTANT 15 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Beclomethasone Dipropionate IP 100mcg + Fumarate Dihydrate BP Eq. to Formoterol 05.01.11 Fumarate 6 mcg Metered Dose Inhaler Beclomethasone Dipropionate IP 100mcg + Formoterol Fumarate Dihydrate BP Eq. to Formoterol 05.01.11 Fumarate 6 mcg Metered Dose Inhaler Beclotiamine Hydrochloride & Beclotiamine Napadisylate (For Veterinary) December-1970 Bedaquiline Tablet 100 mg 14.01.2015 Bemiparin Sodium Solution for injection(5000/7500/10,000 I.U). 8-6-2006 Benazapril Hcl 5mg/10mg/20mg/20mg+Hydrochlorothiazide 6.25mg/12.5mg/12.5mg/25mg tablet 21.05.1998 Benazepril Hcl 5mg/10mg/20mg Tablet 22-4-1996 Bendamustine Hydrochloride lyophilised injection 25mg (Additional strength) 19.9.2014 Bendamustine Hydrochloride 100mg/vial powder for concentrate for solution for infusion 23-12-2016 Bendamustine Hydrochloride Injection 100mg/vial (Additional Indication) 18-05-2011 Bendamustine hydrochloride injection 90 mg/ml (Fill volume 0.5 mL in 2 ml capacity vial & 2 mL 02.03.2017 filled in 2 mL capacity vial Bendamustine hydrochloride injection 90 mg/mL (Fill volume 0.5 mL in 2 ml capacity vial & 2 mL 02.03.2017 filled in 2 mL capacity vial) Bendamustine Hydrochloride Lyophilized powder Injection 100mg/ vial 16.05.09 Bendrofluazide 24.07.2003 Benidipine Hcl 4mg/8mg Film Coated Tablet 12-8-1996 Benorylate 2gm/5ml Suspension December-1978 Benorylate 250mg Tablet December-1978 Benziquinone Guanyl Hydrazone Thiosemicarbazone (Ambazone) 10mg Troches March-1961 Benzoyl peroxide 10%w/w + Precipitated Sulphur 5%w/w per 20gm cream Aug-75 Benzoyl Peroxide Medicated Solution (each textured pad contains 4.5%/6.5%/8.5% of solution 14.05.08 Benzydamine Hcl 3% Topical Cream May-1988 Bepotastine Besilate 1.5 %w/v Ophthalmic solution 22.02.2017 Bepotastine Besilate 10 mg Tablets 27.03.2017 Bepotastine Besilate Bulk 23.11.2016 Bepotastine Besilate Bulk & Bepotastine Besilate 1.5 %w/v Ophthalmic solution 08.06.16 Beriplast (Fibrin Adhesive Glue) 19-6-1996 Besifloxacin Ophthalmic Suspension 0.6% w/v 31.05.11 Betadine Solution containing 10% of Povidone Iodine, Betadine Gargle containing 0.5% of November-1972 Povidone Iodine, Betadine Ointment containing 10% of Povidone Iodine. Betahistine Di hydrochloride CR capsule 24/32/48mg 17.12.2009 Betahistine dihydrochloride April-1975 Betahistine Dihydrochloride SR Tablets 24mg/32mg/48mg 14.3.13 Betahistine Hcl 16mg Tablet 20-1-2000 Betahistine Mesilate Tablet 6mg/12mg 20.02.09 0.05% +Miconazole 2% Cream 12.03.08 Betamethasone 0.05% +Miconazole 2% Cream 12.03.08 Betamethasone 0.5mg Tablet August-1961 Betamethasone Benzoate August-1978 Betamethasone Diprop 0.064%+ Salicylic acid- 3% each ml lotion 14.05.2002 Betamethasone Diprop. 0.064mg + Gentamycin Sulphate Eq to Gentamycin 1mg per ml suspension 25.09.2002 Lotion Betamethasone Dipropionate 0.5mg/g Ointment October-1979 Betamethasone Dipropionate 6.43 mg + Betamethasone Sodium Phosphate 2.63 mg each vial Jul-84 Betamethasone Sodium Phosphate 1mg + Gentamicin Sulphate (eq. to Gentamicin) 1mg (Eye Drops November-1977 & Ointment) Betamethasone-17-Benzoate December-1973 Betamethyl Digoxin 0.1mg & 0.5mg Tablet March-1978 Betamethyl Digoxin 0.1mg Injection March-1978 Betamethyl Digoxin 0.6mg Liquid March-1978 Beta-Methyl Digoxin December-1977 Hcl 0.5% w/v per 5ml Ophthalmic Solution 1-5-1992 Bethanidine Sulphate 10mg & 50mg Tablets June-1968 Bethanidine Sulphate 10mg/50mg Tablets March-1969

PHARMADOCX CONSULTANT 16 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Bezafibrate 200mg Tablet January-1988 Bezafibrate 400mg Film Coated Retard Tablet 2-4-1993 B-Hydroxytheophylline (Bulk) February-1969 Bicalutamide 07.03.2002 Bicalutamide Tablet 150 mg.(Additional Strength and Indication) 05.01.11 Biclotymol May-1986 Biclotymol 0.198gm+Glyceryl Galacolate 0.200gm+Pholcodine 0.133gm+Chlorphenaramine May-86 maleate 0.0133gm per 100ml Syrup (for adult) Biclotymol 0.150gm+Glyceryl Galacolate 0.200gm+Pholcodine 0.100gm+Chlorphenaramine May-86 maleate 0.01gm per 100ml (for children) Bifonazole 0.01gm/1gm Cream/Powder 28-11-1997 Bifonazole 0.01gm/1ml Solution Bimatoprost 0.3mg + Maleate IP Eq. to Timolol 5.0mg eye drops 28.08.2006 Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops 07-05-2006 Bimatoprost (Ophthalmic Sol.) 08.01.2002 Bimatoprost 300mg + Timolol (as maleate) 5mg/ml eye drops 5-7-2006 Bimatoprost Eye Drps 0.1mg/ml 05-08-10 Bimatoprost Ophthalmic Solution 0.01% w/v (Additional Strength) 09.10.10 Bimatoprost Opthalmic solution 0.03% 30.03.09 Bioceramic composite materials: a) Each glass vial contains; Hydroxyapatite 100% granules b) each 22.11.2002 glass contains: hydroxyapatite 90% granules +β tri clacium phosphate 10% granules c) Each vial contains: Hydroxyapatite paste as 30% and 18% suspension Biomesh' GTR barrier (biodegradable) 1-12-1999 Biomycin (of tetracycline) April-1965 Biperiden Lactate 5mg/ml Ampoule October-1972 Biperiden Hydrochloride July-1972 Biphenyl Acetic 3.00% w/w per 15gm tube Gel 27-4-1998 Bisacodyl Tablet & Suppository June-1962 Bismuth Aluminate Tablet April-1962 Bisoprolol Fumarate (2:1) 2.5mg/5mg+Hydrochlorthiazide-6.25mg/6.25 mg Tablet 13.05.1999 Bisoprolol Fumerate (2:1) 5mg/10mg Film Coated Tablet 27-2-1992 Bitoscanate April-1970 Bivalirudin Injection (250mg/vial) 25-08-2005 Bleomycin December-1973 Bleomycin Sulphate 5mg/gm Ointment 11-10-1999 Bleomycin 5mg Injection October-1978 Bleomycin Injection February-1987 Bleomycin Oil Suspension for Injection September-1985 Blonanserin Tablet 2mg/4mg/8mg 24.04.12 Boplant June-1965 Bortezomib 2mg/vial (additional pack size) 28.03.07 Bortezomib 3.5 mg/vial Powder for solution for injection (i.v/s.c) (Additional indication) 11.04.2017 Bortezomib for injection (3.5mg/vial) 18-05-2005 Bortezomib for Injection (i.v) 1 mg/vial (Additional indication) 11.04.2017 Bortezomib for injection 3.5mg (Sub- cutaneous route of administration as an alternate to 28.01.14 intravenous route) (Additional route of administration) Bortezomib inj.3.5mg/vial (Additional Indication) 09.10.08 Bortezomib Injection (additional indication) 05-09-2007. Bosentan (as monohydrate) Tablets 62.5/125mg 23.6.2009 Boswellia Serrata 0.05gm/gm of Cream 28.03.08 Botulinum toxin type A 50 Units/Vial and 100 Units/Vial (Additional Indication) 02-06-2011 Tartrate (2mg/1.5mg) + Timolol (as HCl) (5mg/5mg per) ml. 25-11-2005 Brimonidine Tartrate (2mg/1.5mg) + Timolol (as HCl) 5mg/ml. 25-11-2005 Brimonidine Tartrate 0.2% (eq. to Brimonidine base 0.13%) Ophthalmic Solution 18-5-1999 Brimonidine Tartrate Opthalmic solution 0.1% (with purite as preservation 0.005%) (additional 07.03.08 strength) Brimonidine topical gel 0.33% (Add. Dosage form/indication) 18.06.15

PHARMADOCX CONSULTANT 17 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Brinzolamide - 1.0% w/v 18.02.16 Timolol maleate – 0.683% w/v Eq. to Timolol 0.5% w/v Ophthalmic suspension Brinzolamide 10mg 30.03.16 Brimonidine Tartrate eq. to Brimonidine 2mg Ophthalmic suspension Brinzolamide Ophthalmic Suspension 26.05.11 1%w/v Brivaracetam Film Coated Tablets 50mg/75mg/100mg 07.09.2017 Bromelin 50mg + Pancratin 400mg + Ox bile 30mg (Enzyme) May-1977 Bromfenac Sodium Eye Drop (0.09%) 14.08.08 Bromhexine Hcl 4mg/5ml Elixir September-1979 Bromhexine Hydrochloride 8mg Tablet September-1979 Bromocriptine (as Mesylate) 2.5mg/5mg/10mg Tablet July-1987 Bromocriptine Mesylate Tablet IP 0.8mg, (additional Indication) 22.10.2009 Bromo-Naphthol 250mg Tablet February-1963 Broncho-Vaxom Feb, 2001 Broxyquinoline + Brobenzoxalidine May-63 Buclizine Hcl 25mg Tablet (Additional Indication) 16-01-2010 Buclizine HCl tablet (25mg) & Syrup 6mg/5ml 28-06-2006 200mcg MDI Inhaler February-1988 Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication) 17.10.08 Budesonide + Formoterol (80/160mcg + 4.5mcg) Inhalational Powder (Additional Indication) 17.10.08 Budesonide 320 µ g/inhalation 13.06.2017 Formoterol Fumarate Dihydrate 9µg/inhalation (Additional strength) Each dose delivers: Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 04.01.12 20mcg/20mcg Respirator suspension. (Additional Indication) Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 04.01.12 20mcg/20mcg Respirator suspension. (Additional Indication) Budesonide IP 1mg/0.5mg + Formoterol Fumarate Dihydrate IP eq to Formoterol Fumarate 21.11.11 20mcg/20mcg Respirator suspension. (Additional Strength) Budesonide IP 1mg/0.5mg + Formoterol 21.11.11 Fumarate Dihydrate IP eq to Formoterol Fumarate 20mcg/20mcg Respirator suspension. (Additional Strength) Bulaquine Compound 80/53 21-12-1999 Bumetanide 0.5mg+Potassium Chloride 523 mg tablet Feb-83 Bumetidine 0.25mg/ml Injection August-1980 Bumetidine 1mg Tablet August-1980 Buparvaquone 5% w/v Solution for Injection (For Veterinary) April-1991 Bupivacaine hydrochloride 10mg/ml Hyperbaric Solution December-1974 Bupivacaine Hydrochloride September-1972 Buprenorphin 2 mg + Naloxone (0.5 mg) FDC of 19-08-2004 Buprenorphine Hydrochloride 0.3mg/ml April-1986 Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet 04-06-2005 Buprenorphine (0.4mg) + Naloxone (0.1mg) sublingual tablet 06-04-2005 Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets 02.12.08 Buprenorphine + Naloxone (2 mg/0.4mg + 0.5/0.1 mg) Tablets 02.12.08 Buprenorphine 0.2mg Sublingual Tablet December-1987 Buprenorphine Hcl 0.4mg/2mg Uncoated Tablet 10-3-1999 Buprenorphine HCl eq. to Buprenorphine 2mg+Naloxone Hcl eq.to Naloxone 0.5mg sublingnal 01.08.2004 tablets Buprenorphine Transdermal Patch Each Transdermal Patch having an area of 6.25cm², 12.5cm², 03.09.09 and 25cm²contains: Buprenorphine…5mg/10mg/20 mg having release rate of 5mcg, 10mcg, 20mcg Buprenorphine per hour respectively(over a period of 7 days). SR 10.04.2001 Buserelin Acetate 4mcg/ml Injection (For Veterinary) April-1986

PHARMADOCX CONSULTANT 18 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Buserelin Acetate injection 1mg/ml (Additional Indication) 08.09.10 Hcl 5mg/10mg Tablet October-1990 Butafostane 10gm + Cyanocobalamine 0.005gm per 100ml Solution 04.03.1998 Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder 19.03.09 (Veterinary Drug) Butaphosphan 100g + Methyl Hydroxybenzoate 1gm + Cyanocobalamin50 gm Oral powder 19.03.09 (Veterinary Drug) Butarphenol Tartarate 11.09.2002 Butarphenol tartrate 10mg/ml nasal spray 26.11.07 Butenafine HCl 10mg+ Betamethasone Dipropionate eq. to Betamethasone 0.5mg cream 15.03.2002 Butenafine HCl cream 14.02.2001 Cabazitaxel Injection 60mg / 1.5ml 16.11.11 Cabergoline 05.09.2002 Cabergoline 1 mg/2 mg/4 mg tablets 07-05-2004 Cabergoline 1mg tablet (additional strength) 06.03.07 Cabergoline 1mg Tablets (Additional indication) 01.10.08 Caffein 100mg + tartrate 1mg + Analgin 250mg + Trifluperazine HCl 1mg Capsule Mar-76 Caffeine Citrate 20mg / ml (equivalent to 10mg of Caffeine base) Oral Solution (Addl. 18.7.2009 Dosage form) Caffeine(as Citrate)10mg / ml Injection 16.05.09 Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% w/v+Glycerin 5%w/v + Sodium citrate 08.05.2009 0.05 % w/v lotion Each ml contains Calamine 8% + Liquid Paraffin10% lotion 26.02.09 Calamine 8% + Liquid Paraffin10% lotion 26.02.09 Calcipotriol 50mcg + Betamethasone 0.5mg Ointment 16.08.2005 Calcipotriol Gel 0.005% (additional dosage form) 3.10.2009 Calciptriol (50mcg) + Betamethasone Dipro (0.5mg) per gm Ointment FDC of 08-12-2005 Calciptriol (50mcg) + Betamethasone Dipro (0.5mg/gm) Ointment FDC of 12-08-2005 Calcitriol 0.25mcg + Calcium 200mg + Zinc 7.5mg Capsules 11.04.2008 Calcitriol 1mcg/2mcg per ml Injection 19-3-1994 Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules 04.11.08 Calcitriol + Calcium + Zinc (0.25mcg + 200mg + 7.5mg) Capsules 04.11.08 Calcitriol 0.5mcg/0.25mcg Soft Gelatin Capsule 27-8-1993 Calcium Dobesilate 500mg Capsule 22-9-1997 Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid 30.09.08 (250mg + 100IU + 50mcg) Tablets Calcium (as Calcium Citrate Malate) + Colecalciferol (as Colecalciferol Concentrate) + Folic Acid 30.09.08 (250mg + 100IU + 50mcg) Tablets Calcium acetate 435mg + Magnesium carbonate 235mg tablets 05-03-2010 Calcium acetate 435mg + Magnesium carbonate 235mg tablets 03-05-2010 Calcium and Magnesium 24% (Veterinary) injectable solution. 13.09.08 Calcium carbonate 600mg + Simethicone 80mg Chewable tablet 28-05-2010 Calcium carbonate 600mg + Simethicone 80mg Chewable tablet 28-05-2010 Calcium chloride dihydrate 0.184 g/l + Glycine 0.51 g/l + L- Alanine 0.951 g/l + L- Arginine 1.071 18.04.12 g/l + L- Isoleucine 0.85 g/l + L- Histidine 0.714 g/l + L- Leucine 1.02 g/l + L- Lysine (as Hcl) 0.955 g/l + L-Methionine 0.85 g/l + L- Phenylalanine 0.57 g/l + L-Proline 0.595 g/l + L- Serine 0.51 g/l + L- Threonine 0.646 g/l + L-Tryptophan 0.27 g/l + L-Tyrosine 0.3 g/l + L-Valine 1.393 g/l + Magnesium chloride hexahydrate 0.051 g/l + Sodium chloride 5.38 g/l + Sodium lactate 4.48 g/l Sterile Solution for Peritoneal Dialysis Each 1000 ml contains: Calcium citrate maleate Eq. to elemental calcium 250mg +Vitamin D3 IP 200 IU tablet 13.10.10 Calcium citrate maleate Eq. to elemental calcium 250mg +Vitamin D3 IP 200 IU tablet 13.10.10 Calcium gluconate 50mg + Iso thipendyl HCl 4mg + Acetylsalicylic acid 200mg + Caffine 30mg Jun-72 per dosage Calcium Hypochlorite 4gm Sachet (Calcium Hypochlorite 0.542% Other Ingredients: 99.458%) 23.11.08

PHARMADOCX CONSULTANT 19 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Calcium loaded sulfonated polystyrene cation exchange resin 0.5gm (eq. to 1.8mEq Ca++) cross 13-9-1993 linked with 8% divinyl benzene Soft Gelatin Capsule Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU 23-10-2007. Calcium Pidolate equivalent to Calcium 500mg + Vit-D3 250 IU powder for oral use 23-10-2007. Calcium Polycarbophil (500mg) Tablet 06-07-2005 Calcium Polycarbophil (500mg) tablet 23-12-2004 Calcium Succinate + Iron Edetate Sodium November-1969 Calender pack containing 21 days1. Levonorgestrel 0.05mg + Ethinyloestradiol 0.03mg Tablet 2. Jun-81 Levonorgestrel 0.075mg + Ethinyloestradiol 0.04mg Tablet 3. Levonorgestrel 0.125mg + Ethinyloestradiol 0.03mg Tablet and 7 inactive tablets extra Calf lung surfactant Intratracheal Suspension containing Phospholipids.... 35mg (containing 26 mg 17.02.11 phosphatidylcholine of which 16mg is disaturated phosphatidylcholine) Proteins....0.65mg (including 0.26mg of surfactant associated proteins B) per ml Camostat Mesylate tablets 100mg 29.01.08 Canagliflozin Tablet 100/300mg 17.11.14 Candesartan Cilexetil 4mg/8mg/16mg Tablet 31-8-2000 Candesartan Cilexetil- 16mg+Hydrochlorothiazide-12.5mg tablet 03.01.2002 Candur P. Parvovirus Vaccine (For Veterinary) 9-7-1992 Candur-R (Purified Chick Emryo Cell Rabies Vaccine) (For Veterinary) 13-8-1993 Canine Distemper Killed Canine Hepatitis Leptorpira Parvo Virus Vaccine (For Veterinary) November-1986 Cape aloes 16mg + Podophyllin resin 4.2mg + Licorice powder 5.462 mg per Tabler Oct-72 Capecitabin Tablet (150mg/500mg). (for additional indication). 16-07-2007. Capecitabine 150/500mg Tablets (addl. Indication) 02.09.08 Capecitabine 150mg/500mg Film Coated Tablet 12-10-2000 Captopril 25/50mg + HCTZ 15/25mg Jul-89 Captopril 25mg/50mg Tablet October-1985 Carbadox (For Veterinary Use) July-1975 Carbamezepine 200mg/400mg C.R Film Coated Tablet 17-5-1993 Carbazochrome Salicylate (eq. to Adrenochrone Monosemicarbazone) 5mg/ml Injection September-1969 Carbenicillin Disodium 1gm/vial Injection August-1973 Carbenoxolone Sodium 50mg Tablet January-1974 Carbenoxolone Sodium December-1973 Carbidopa (Anhydrous) 50mg + Levodopa- 200mg C.R.tablet 12.10.1994 Carbocaine 2%-20mg Injection February-1987 Carbocisteine August-1987 Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 24.12.08 mg + 120 mg) syrup Carboinoxamine Maleate + Ammonium Chloride + Sodium Citrate (Each 5 ml contains: 2 mg + 120 24.12.08 mg + 120 mg) syrup Carboplatin 50mg/150mg + Mannitol IP 50mg/150mg per vial Injection & Bulk March-1989 Carboprost Tromethamine May-1986 Carboprost Tromethamine 250mcg/ml Sterile Solution March-1979 Carboquone 0.25mg/0.5mg Tablet August-1985 Carboquone 1mg/vial Injection August-1985 Carboxy Methyl Cellulose Sodium Lubricant Eye Drops 0.5% w/v (Unit dose pack without 27.5.13 preservative) Carenecaine 2% with & Carenecaine 4% with Adrenaline Injectio Feb-87 Carfilzomib Sterile Lyophilized Powder for Injection 60mg/vial (50ml vial) 17.01.17 Carisoprodol March-1965 Carmustine (polifeprosan 20 with carmustine Implant (Wafer) 31.01.08 Carmustine for inj. 100 mg 10-06-2010 Caroverine cap. 20mg & Inj. 40mg/2ml 23-08-06 Hcl 2% w/v Sterile Ophthalmic Solution 9-7-1996 Carteolol Hcl 5mg Film Coated Tablet 9-7-1996 3.125mg/6.25mg (new strength) 10-3-1999 Carvedilol 12.5mg/25mg Tablet 16-10-1998 Carvedilol Phosphate ER tablet 10/20/40/80mg 11.12.2009

PHARMADOCX CONSULTANT 20 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

CarvedilolTablets 3.125/6.25/12. 5/25mg (additional indication) 09.05.2009 Caspofungin Acetate injection (50mg/70mg per vial). 23-12-2005 Caspofungin acetate Injection (Addl. Indication) 31.01.09 Catalin January-1976 Cefaclor 375mg/750mg MR Tablet 27-1-1995 Cefaclor Monohydrate 250mg/500mg Capsule. iCefaclor Monohydrate 125mg/5ml & 250mg/5ml April-1991 Suspension. Cefaclor Monohydrate 100mg/ml Drops. Cefaclor 187mg/5ml Suspension (For paediatric use). Cefadroxil 125mg/250mg per 5ml Oral Suspension February-1989 Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet 30-08-06 Cefadroxil 500mg + Clavulanic acid 125mg film coated tablets 30-08-06 Cefadroxil 250mg + Clavulanic acid 62.5mg dispersible tablet 30-08-06 Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup 30-08-06 Cefadroxil 250mg + Clavulanic acid 62.5mg per 5ml syrup 30-08-06 Cefadroxil 250mg Dispersible Tablet February-1989 Cefadroxil 500mg + Clavulanic acid 125mg tablet 30-08-06 Cefadroxil 500mg/1gm Tablet/Capsule February-1989 Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup 25.07.08 (Additional strength) Cefadroxyl (as monohydrate) 125mg + Clavulanic acid (as potassium) 31.25 per 5ml Syrup 25.07.08 (Additional strength) Cefazolin Sodium 250mg/500mg/1g per vial Injection September-1985 Cefdinir 10.10.2001 Cefdinir 250mg dispersible tablets & oral suspension 250mg/5ml 29.04.08 Cefdinir Dispersible tablet (125mg) 27-05-2004 Cefditeron (as pivoxil) 200mg tablet 3-3-2006 Cefditoren pivoxil 400mg tablets (Additional Strength) 11.03.08 Cefditoren Pivoxil dry powder for suspension 100 mg/5 mL 30.03.2017 Cefditorene pivoxil dispersible tablet (30mg/50mg) (New Dosage form for children) 08.06.07 Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Injection 08-11-2006 Cefepem (as Hcl) 0.5/1gm + Amikacin (as sulphate) 0.125/0.250gm Inj. 11-8-2006 Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength). 30-07-2007. Cefepime (250mg) + Tazobactam (31.25mg) Injection (addl. Strength). 30-07-2007. Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg 30-08-06 Cefepime (As Hcl) 500mg/1000mg + Tazobactum (as Sodium) 62.5mg/125mg per injection 30-08-06 Cefepime (as hydrochloride) 2000/1000/500mg + Sulbactam (as sodium) 1000/500/250mg per vial 24.01.08 of injection Cefepime (as hydrochloride) 2000/1000/500mg 24.01.08 + Sulbactam (as sodium) 1000/500/250mg per vial of injection Cefepime Injection (New indication) 14-06-2007. Cefepime injection 500mg/1gm/2gm (For additional indication) 14.06.07 Cefepine HCl 30.10.2002 Cefetamet Pivoxil Hcl oral suspension 250mg/ml 16-02-2006 Cefetamet Pivoxil Suspension 250 mg/5ml 09-08-2004 Cefetemet-piroxil 14.11.2002 Cefixime 200mg + Pot. Clavulanate (125mg) tablet 20-07-2006 Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet 31.08.10 Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tablet 29-08-06 Cefixime (50mg/100mg) + Clavulanic acid 31.125mg/62.5mg per ml dry syrup & tablet 29-08-06 Cefixime (SR) 400mg +Moxifloxacin (SR) 400 mg Tablets 08.08.11 Cefixime (SR) 400mg +Moxifloxacin 08.08.11 (SR) 400 mg Tablets Cefixime 100mg + Cloxacillin (as Sodium) 500mg + Lactobacillus (45 million spore)tab. 31-08-06 Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets 02-12-2010 Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets 26-04-2010 Cefixime 100mg/200mg + Cloxacillin (as Sodium) 500mg/500mg + Lactobacillus (45 /90 Million 31-08-06 spore)tablet

PHARMADOCX CONSULTANT 21 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Cefixime 100mg/200mg + Cloxacillin 500mg/500mg tablets 12-02-2010 Cefixime 100mg/200mg + Ofloxacin 100mg/200mg Tablets 26-04-2010 Cefixime 100mg/200mg/400mg Capsule/Tablet 24-2-1993 Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets 22.09.2009 Cefixime 200 mg + Dicloxacillin ER 500 mg Tablets 22.09.2009 Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional 14-11-06 strength) Cefixime 200mg + Cloxacillin 500mg (ER) + Lactobacillus 90 million Spore tab. (additional 14-11-06 strength) tablet Cefixime 200mg + Pot. Clavulanate (125mg) tablet 20-07-2006 Cefixime 200mg/100mg + Lactic acid bacillus 2.5 billion spores tablet & dispersible tablet 07.01.08 Cefixime 200mg/100mg + Lactic acid bacillus 07.01.08 2.5 billion spores tablet & dispersible tablet Cefixime dispersible tablet 400mg (new dosage Form) 22-11-06 Cefixime SR 200mg/400mg + Ofloxacin SR 200mg/400mg Tablet 31.08.10 Cefixime Tablets 200mg &Cefixime Oral Suspension 100mg/5ml 22.2.13 Cefixime Trihydrate IP Eq. to Anhydrous Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg 20.04.11 Dispersible Tablet Cefixime Trihydrate IP Eq. to Anhydrous 20.04.11 Cefixime 100mg/200mg + Ofloxacin IP 100mg/200mg Dispersible Tablet (Additional dosage form ) Cefoperazone Sodium 1g/2g per vial Injection 23-8-1993 Cefoperazone 500/1000mg + Tazobactum 62.5/125mg Injection 4.11.2009 Cefoperazone sod. Eq. to Cefoperazone 1g/2g+ Sulbactum Sod. Eq. to Sulbactum 0.5g/1g each vial 12.06.2001 Injection Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for 18.05.07 additional indication) Cefotaxim (As sodium) 0.5mg/1gm + Sulbactam (As sodium) 250mg/500mg injection (for 18.05.07 additional indication) Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication) 24.06.08 Cefotaxime 0.25gm/0.5gm/1gm/2gm per vial Injection June-1987 Cefotaxime Sodium April-1987 Cefotaxime sodium + Sulbactam sodium for injection (Additional Indication) 24.06.08 Cefovecin( as sodium) 80mg/ ml Lyophilised powder for injection (Veterinary) 03.10.09 Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg 24.01.08 powder for injection Cefpirome (as sulphate) 500/1000mg/2000mg + Sulbactam (as sodium ) 250mg/500mg/1000mg 24.01.08 powder for injection Cefpirome Sulfate 0.25g/0.5g/1.0g/2g per vial Injection 26-9-1997 Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet. 30-07-2007. Cefpodoxime 200/100mg + Clavulanate Potassium 125/62.5mg Tablets 30.07.2007 Cefpodoxime IP 100mg/100mg/200mg/200mg +Ofloxacin IP 100mg/200mg/100mg/200mg 16.04.11 Tablets Cefpodoxime (as Proxetil) (100mg/200mg) + Clavulanic acid (62.5/125mg) tablet. 30-07-2007. Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg Tablet 08-06-2010 Cefpodoxime 100/200mg+Dicloxacillin ER 500/500mg 06-08-10 Cefpodoxime 100mg + Clavulanate Potassium 62.5 mg Dispersible Tablet/Dry Syrup 31.01.2008 Cefpodoxime 100mg + Ofloxacin 100mg Dispersible Tablet (Additional Dosage form) 29.11.2012 Cefpodoxime 100mg + Ofloxacin 100mg Dispersible Tablet (Additional Dosage form) 29.11.2012 Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength) 31.01.08 Cefpodoxime 50mg + Clavulanic acid 31.25mg dispersible tablet & dry syrup (Additional strength) 31.01.08 Cefpodoxime IP 16.04.11 100mg/100mg/200mg/200mg +Ofloxacin IP 100mg/200mg/100mg/200mg Tablets Cefpodoxime Proxetil 100mg Tablet 12-3-1996 Cefpodoxime Proxetil 40mg/5ml Dry Syrup

PHARMADOCX CONSULTANT 22 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Cefpodoxime Proxetil 100mg Tablet 19-9-1997 Cefpodoxime Proxetil 40mg/5ml Suspension Cefprozil 10-01-2003 Cefprozil 250mg/500mg+Clav. Acid-62.5mg 12.11.07 /125mg. tab Cefprozil 250mg/500mg+Clav. Acid-62.5mg /125mg. tab 12.11.07 Cefprozil Dispersible Tablet (125 mg/ 250 mg) 22-06-2004 Cefprozil Powder for oral suspension (125mg/5ml) 6-1-2006 Ceftaroline Fosamil Injection 600 mg/Vial 09.05.2016 Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength) 05.08.08 Ceftazidime 250mg + Tazobactam 31.25mg Injection 31.07.2007 Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) 08.01.08 Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection 08.06.07 Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection 24.12.08 Ceftazidime + Sulbactam (500/1000mg + 250/500mg) Injection 24.12.08 Ceftazidime + Tobramycin injection (1gm + 120mg) (Additional Strength) 05.08.08 Ceftazidime 250mg/500mg/1gm/2gm per vial Injection June-1988 Ceftazidime 500mg + Tobramycin 60mg per injection 08.01.2008 Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injection 30-08-06 Ceftazidime 500mg /1000mg + Tazobactum (as sodium) 62.5mg/125mg per vial for injection 30-08-06 Ceftazidime 500mg + Tobramycin 60mg per vial (Injection) 08.01.08 Ceftazidime 500mg/1000mg + Sulbactam (As Sodium) 250mg/500mg For injection 08.06.07 Ceftazidine (2gm) + Sulbactam (1gm) Injection (addl. strength for additional indication). 06-09-2007. Ceftazidine (2gm) + Sulbactam (1gm) Injection ( addl. strength for additional indication). 06-09-2007. Ceftibuten 200mg/400mg Capsule 19-11-1996 Ceftibuten (on reconstitution) 90mg/180mg per 5ml Suspension Ceftiofur Crystalline free acid Suspension equi to Ceftiofur ---- 200 mg(veterinary) 26.09.08 Ceftiofur HCl Suspension (as HCl salt) ----125mg (veterinary) 26.09.08 Ceftiofur HCl Suspension(as HCl salt) ----500mg (veterinary) 26.09.08 Ceftiofur Sodium & Ceftiofur HCl Antibiotic (For Veterinary Use) 08.10.2002 Ceftizoxime Sodium Sterile 500mg/1000mg each Vial April-1990 Ceftriaxone –2gm+ Tazobactum 250mg for injection 21.11.07 Ceftriaxone (500mg/1000mg) + Tazobactum (62.5mg/125mg) Injection FDC of 21-07-2005 Ceftriaxone 0.125/0.25/0.5/1g + Tazobactam 15.625/31.25/62.5/125mg injection 21.07.2005 Ceftriaxone 2gm + Sulbactam 1gm injection (Additional Indication) 18.08.08 Ceftriaxone (500mg/100mg) + Tazobactum (12.5mg/62.5mg) Injection FDC of 21-07-2005 Ceftriaxone (as sodium) (500mg/1000mg) + Sulbactam (as sodium) (250mg/500mg) powder for 12-08-2005 injection. Ceftriaxone (as sodium) (500mg/1000mg) 08-12-2005 + Sulbactam (as sodium) (250mg/500mg) powder for injection. Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg For injection 01.03.07 (additional strength) Ceftriaxone (As sodium) 125mg/250mg + Sulbactam (As sodium) 62.5mg/125mg For injection 01.03.07 (additional strength) injection Ceftriaxone (as sodium) 250mg + Tazobactam 31.25 mg for injection (addl. Strength) 5-7-2006 Ceftriaxone (as sodium) 250mg + Tazobactam 07-05-2006 31.25 mg for injection (addl. Strength) Ceftriaxone + Sulbactam injection (Additional Indication) 18.08.08 Ceftriaxone –2gm+ Tazobactum 250mg for injection 21.11.07 Ceftriaxone Sodium 250mg/500mg/1gm per vial Injection April-1988 Ceftriaxone Sodium eq. to Ceftriaxone Sodium 1000mg/2000mg + Sulbactam Sodium eq. 21.09.11 Sulbactam 500mg/1000mg.injection Ceftriaxone Sodium eq. to Ceftriaxone 21.09.11 Sodium 1000mg/2000mg + Sulbactam Sodium eq. Sulbactam 500mg/1000mg.injection Cefuroxime Sodium 750/1500mg +Sulbactam Sodium 375/750mg Injection 07-06-2010

PHARMADOCX CONSULTANT 23 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Cefuroxime 250mg + Clavulanic Acid 125mg FC tablet/Dry syrup 10.05.2007 Cefuroxime 250mg/750mg/1.5gm per vial Injection June-1988 Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet. 27-09-2007. Cefuroxime Axetil (250mg) + Clavulanic acid (125mg) tablet. 05-10-2007. Cefuroxime Axetil (250mg) + Clavulanic Acid (125mg) Tablet. 27-09-2007. Cefuroxime Axetil (250mg) + Clavulanic acid (125mg) tablet. 05-10-2007. Cefuroxime Axetil 125mg/250mg/500mg Tablet May-1990 Cefuroxime Axetil ER tablets (500 mg/ 1000mg) 06-10-2004 Cefuroxime Sodium 250mg intramammay infusion for Veterinary (PFS) (New dosage form) 13-12-2011 Cefuroxime Sodium 750/1500mg 06-07-10 +Sulbactam Sodium 375/750mg Cefuroxime-125/250/500mg +Clavulanic Acid- 31.25/62.5/125mg film coated tablet 10-05-2007 Cefuroxime-125/250/500mg 5-10-2007 +Clav.Acid-31.25/62.5/125mg Celecoxib 100/200mg +Diacerein 50/50mg Capsule 19-07-10 Celecoxib 100/200mg +Diacerein 50/50mg 19-07-10 Celecoxib 100mg/200mg Capsule 22-2-2000 Celecoxib Injection (100 mg/ml) 28-10-2004 Celecoxib Mouth Dissolving Tablet 50/100/200 mg 25-02-2010 Hydrochloride 100mg/200mg/400mg Film Coated Tablet 1-12-1994 Centbucridine (0.5%) + Feracrylem (3%) 11-01-2005 Centbucridine (0.5%) + Feracrylem (3%) Gel 01-11-2005 Centbucridine 0.5% Injection August-1985 Centbutindole (Bulk) December-1986 Centbutindole 1.5mg Tablet February-1987 Centchroman 30mg Tablet November-1990 Centpropazine 20mg Capsule 16-8-1996 Cephacetrile Sodium 235mg in 10gm of suspension Intramammary Infusion (For Veterinary) 13-5-1992 Cephalaxin anhydrous 250mg+Carbocisteine 150mg per 5 ml suspension 30.10.1994 Cephalaxin monohydrate eq. to cephalexin 500mg/250mg+Carbocisteine 150mg/150mg Capsules 30.10.1994 Cephalexin October-1971 Cephalexin 1gm Tablet October-1988 Cephalexin Anhydrous 375mg/750mg ER Film Coated Tablet 17-11-1998 Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension 07.03.12 per 10 gm Intramammary Suspension Cephalexin IP (as monohydrate) 200mg + Kanamycin IP (as monosulphate) 100,000 IU Suspension 07.03.12 per 10 gm Intramammary Suspension Cephalexin monohydrate eq. to cephalaxin 125mg/250mg+ Bromhexine Hcl eq. to Bromhexine 27.01.1995 2mg/4mg per 5ml of reconstituted suspension. Cephalexin-250mg/500mg+ Bromhexine (as HCl) 4MG/8MG Capsules 16.09.1994 Cephalothin Sodium (Bulk) December-1980 Cephradine January-1976 Cephradine 250mg/500mg Capsule March-1976 Cephradine 250mg/5ml Suspension March-1976 Cephradine 250mg, 500mg &1gm Each vial contains; March-1976 Cerebrolysin solution for injection. Each ml contains: Porcine brain derived peptide preparation 25.07.2014 (Cerebrolysine concentrate) 215.2mg Cerebroprotein 04.11.10 Hydrolysate injection (Lyophilised) …..1050mg / 2100mg (approx) equivalent to nitrogen….30mg / 60mg respectively. Ceritinib 150 mg Hard Gelatin Capsules 13.01.2015 Cerivastatin Sodium 100mcg/200mcg/ 300mcg Tablet 11-5-2000 Certoparin Sodium 3000 IU per disposable syringe of 0.3ml solution Injection October-1999 Cetirizine Dihydrochloride 5mg (Immediate release)+ HCl 120mg (SR) tablet 09.09.1997 Cetirizine HCl drops (10mg/ml) 08-11-2005

PHARMADOCX CONSULTANT 24 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate 09.02.09 Solution Cetrimide15% w/v + Chlorhexidine Gluconate 7.5% v/v + Isopropyl Alcohol 7.5% v/v Concentrate 09.02.09 Solution Cetrizine 10 mg + Ambroxol 75 mg SR Tablet 13.04.2009 Cetrizine 10 mg + Ambroxol 75 mg SR Tablet 13.04.2009 Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup 23.02.09 Cetrizine 5/10mg + Ambroxol 30mg per 5ml syrup 23.02.09 Cetrizine Dihydrochloride 20mg/10mg/5mg Film Coated Tablet 25-6-1993 Cetrizine DHC 10mg/10ml Syrup Cetrizine DHC 10mg/ml Drops Cetrorelix Acetate injection 0.25mg/0.5ml in 0.5 ml prefilled syringe. 26-08-15 (Additional pack size) Chandonium Iodide 2mg/ml 2ml ampoule Injection 1-3-1994 Chelated Amino Acid based minerals 20-7-1993 Chemically Modified Sodium Hyaluronate 11-02-2010 and Caboxymethylcellulose Absorbable Adhesion Barrier. Chenodeoxycholic Acid 250mg Capsule December-1987 Chlophedianol hydrochloride 5% drops April-1961 Chloramphenicol Palmitoyl Glycolate Suspension May-1961 Chloramphenicol 500mg Capsule October-1972 Chlordantoin August-1970 Chlordentoin 1% + Benzyl bromide chloride 0.05% per 100gm cream Sep-70 Chlordiazepoxide 5mg + Clidimium bromide 2.5mg per tablet Jul-73 Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v Solution 29.12.2010 Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v Syrup 29.12.2010 Chlorhexidine gluconate IP 1%w/v + Ethyl Alcohol IP 61%w/v Solution 29.12.2010 Chlormezanone 100mg Tablet August-1962 Chlorohexidine Gluconate Gel 0.2% 30.12.2009 Chlorohexidine Gluconate Mouth wash 0.1% 30.12.2009 Chloroquine Phosphate eye drops (0.3mg/ml) 13-07-2005 Chlorpheniramine maleate 4 mg Codeine phosphate 10 mgEach 5 ml conatins: 10.03.95 Chlorpheniramine Maleate IP 2mg + Dextromethorphan Hydrobromide IP 10mg + Phenylephrine Approved for Hydrochloride IP 5mg Softgel Capsule more than 4 years Chlorpheniramne Maleate USP 8mg Sustained Release Tablet April-1978 Chlorphenoxamine Embonate 17.5mg/5ml Syrup March-1979 Chlorphenoxamine Hcl 12mg Tablet March-1971 Chlorphenoxamine HCl 12mg + Caffeine 30mg Tablet Jul-72 50mg + Trifluroperazine 5mg + Trihexyphenidyl 2mg tablet May-79 Chlorprothixene 50mg Tablet & 50mg Vial September-1961 Chlorthalidone September-1963 Chlorthalidone 100/200mg Tablet March-1961 Chlorthalidone Tablet 6.25mg 03.10.09 Chlorzoxazone 250mg Tablet April-1963 Chlosal Butamide Ointment/Solution/Dusting Powder October-1963 Cholestyramine Powder for oral suspension (4gm/sachet) 30-03-2006 Choline Fenofibrate DR Capsule 45mg/135mg & DR Tablet 45mg/135mg. 01.11.12 Choline Salicylate 8.7% Solution November-1978 Choline Salicylate Solution April-1965 100mg/200mg + Formoterol 6mcg/6mcg + Tiotropium 9mcg/9mcg Rotacaps 31.01.2008 Ciclesonide 160mcg/320mcg + Formoterol Fumarate (12mcg) (Dry powder inhaler additional 27.02.07 strength) Ciclesonide 160mcg/320mcg + Formoterol Fumarate 12mcg/12mcg (Dry powder inhaler additional 27.02.07 strength) rotacap Ciclesonide 160mcg/320mcg cap. for inhalation 28-11-06 Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler 31.01.08 Ciclesonide 160mcg/320mcg/Formoterol 12mcg + Tiotropium 18mcg Dry powder inhaler 31.01.08

PHARMADOCX CONSULTANT 25 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Ciclesonide 200mcg + Formoterol 6mcg +Tiotropium 9mcg MDI 13.04.2009 Ciclesonide 200mcg + Formoterol 6mcg + Tiotropium 9mcg MDI 13.04.2009 Ciclesonide Inhaler 80/160mcg per actuation 6-2-2006 Ciclesonide Nasal Spray 50mcg/spray 08.06.07 Ciclesonide rotacaps (200/400mcg) 19-05-2006 Ciclopirox Olamine 10mg/ml Solution October-1985 Ciclopirox Olamine 10mg/1gm Cream October-1985 Ciclopirox Olamine 10mg/1gm Vaginal Cream October-1985 Ciclosonide 80mcg/160mcg/200mcg/400mcg + Formoterol 4.5mcg/4.5mcg/6mcg/6mcg Inhaler 29.08.2006 & Rotacaps Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps 29-08-06 Ciclsonide 100mcg/ 200mcg/400mcg + Formotorol Fumarate 6mg rotacaps 29-08-06 Ciclsonide 80mcg/160mcg + Formotorol 4.5mg inhaler 29-08-06 Ciclsonide 80mcg/160mcg+ Formotorol 4.5mg/4.5mg inhaler (rotacap) 29-08-06 Cifixime 200mg + Erdosteine 300mg Capsules 21.03.07 Cifixime 200mg + Erdosteine 300mg Capsules 21.03.07 Cilnidipine Tabs. 5mg, 10mg 21-6-2007 Cilostazol 23-01-2003 Cilostazole E.R Tablet (100mg/200mg). 30-10-2007. Cimetidine 100mg/ml Injection May-1980 Cimetidine 200mg Tablet/Capsule June-1980 Cimetidine 200mg/5ml Syrup June-1980 Cimetidine Hydrochloride 100mg/ml Injection September-1985 Cimetropium Bromide tablet 50mg 31.01.08 Cinacalet (as HCl) Tablet 30/60/90mg 14.01.09 Cinitapride (as hydrogen tartrate) 1mg tablet 04.01.08 Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules 12-05-2010 Cinitapride (ER) 3mg + Omeprazole (EC) 20mg Capsules 05-12-2010 Cinitapride Hydrogen Tartrate ER Tablet 3mg 26.11.2009 Cinnarazine 20mg + Domperidone 15mg tablet 01-02-1992 Cinnarizine 20mg + Dimenhydrinate 40mg tablets 02-03-2010 Cinnarizine 20mg + Dimenhydrinate 40mg tablets 03-02-2010 Cinnarizine 25mg/15mg Tablet August-1985 Ciprofibrate 100mg Tablet 1-5-1998 Ciprofloxacin (0.3%)+Dexomethasone (0.1%) eye drops 17.07.1999 Ciprofloxacin 0.3% w/v Eye Drops/Eye Ointment/Ear Drop February-1991 Ciprofloxacin 0.3%w/v+ Dexomethasone 0.1% w/v eye drops 29.09.1999 Ciprofloxacin 1g SR Aug, 2001 Ciprofloxacin HCl eq. to Ciprofloxacin 500mg+ Ornidazole 500mg film coated tablet 03.02.2003 Ciprofloxacin Hcl Monohydrate 250mg/500mg/750 Tablet May-1989 Ciprofloxacin Lactate 100mg/50ml & 200mg/100ml Infusion May-1989 Cisapride + M.P.S. Chewable tablet 03.05.1993 Cisapride 5mg/10mg/20mg Tablet & Cisapride 1mg/ml Suspension. 6-11-1992 Cisplatin 10mg/50mg per vial Injection April-1982 Citalopram Hydrobromide 03.10.2001 Citicholine 500mg + Piracetam 400mg Tablets 16-03-2010 Citicholine 500mg + Piracetam 400mg Tablets 16-03-2010 Citicholine Syrup 750mg/5ml 04.01.08 Citicholine Tablet 500 mg & Injection 250 mg/ml 20-08-2004 Citicholine(as Sod.)-200mg/500mg /750mg granules per sachet. 26.11.07 Citicoline (750mg) tablet (additional strength), syrup 500mg/5ml (new dosage Form) (not For 10.04.07 children) Citicoline 500mg +Piracetam 400mg per 5 ml syrup 11.10.10 Citicoline 500mg +Piracetam 400mg per 5 ml syrup (additonal dosage) 11.10.10 Citicoline Chewable tablet (500mg) 18.08.08 Citicoline CR Tab 1000mg 16.09.08 Citicoline Oral Drops 30.09.08

PHARMADOCX CONSULTANT 26 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Citicoline tablet 200mg (additional strength) 25.05.07 Citicoline Troches 200/500mg 31.10.08 Cladribine 09-09-2003 Clarithromycin 250mg/500mg Tablet iClarithromycin 125mg/250mg per ml Paediatric Suspension 22-3-1995 Clavulanic Acid February-1987 Clavulanic acid (As potassium salt) 200mg + Amoxycillin (As sodium salt) 1gm injection 07.08.1990 Clebopride (as Malate) (1)Tablets...0.5 mg Ph. Eur. 04.11.10 (2.) Syrup...0.1 mg / ml Ph. Eur. (3.) Injection...1 mg / 2mlPh. Eur. Clemastine April-1979 Clemastine (as the hydrogen fumerate) 0.5mg/5ml Elixir September-1985 Clemustine (as the hydrogen fumerate) 1mg Tablet September-1985 Hydrochloride Solution for injection 30mcg/ml 01.07.2012 Clestabol 500mg+Neomycin Sulphate 500mg per 100gm cream Jun-85 Clidinium bromide 2.5mg + Diazepam 2.5mg + Analgin 500mg tablet Sep-79 Clidinium Bromide 2.5mg/5mg Tablet May-1962 Clindamycin October-1981 Clindamycin 1% + Benzoyl peroxide 5% cream 10.9.2004 Clindamycin 1% + Isotretinoin 0.05% gel 08.03.07 Clindamycin 1% + Isotretinoin 0.05% gel 08.03.07 Clindamycin 1%+Tretinoin 0.025% Topical gel 18.11.1996 Clindamycin Palmitate Hcl For Oral Solution 75mg/5ml. 14.12.2010 Clindamycin Phosphate 1% per gm Topical Gel October-1992 Clindamycin Phosphate eq. to Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous 30.08.11 Benzoyl peroxide 2.5% w/w topical gel Clindamycin Phosphate eq. to 30.08.11 Clindamycin 1% w/w + Hydrous Benzoyl Peroxide eq. to Anhydrous Benzoyl peroxide 2.5% w/w topical gel Clindamycin Phosphate Inj. 150mg/ml & 02.05.2009 Clindamycin HCl Capsules 150mg/300mg (additional indication) Clobazam 5mg/10mg/20mg Tablet 11-11-1997 Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment. 20-07-2006 Clobestasol Propionate (0.05%) + Calcipotriol Ointment (0.005%) Ointment. 20-07-2006 Clobetasol Propionate 0.05% Cream/Ointment October-1987 Clobetasol Propionate 0.05 % w/w+Ammonium lactate 12 % w/w gel 07.08.1996 Clobetasone 17-butyrate September-1986 Clobetasone 17-butyrate 0.05% Cream/ Ointment December-1986 Clofazemine 50mg/100mg September-1969 Clofibrate 250mg Capsule July-1967 Clomiphene Citrate B.P 50mg Tablet February-1974 Hcl 50mg Capsule February-1992 Clomipramine Hcl 75mg SR Tablet 19-10-1994 Clomipramine Hcl 10mg/25mg/50mg Tablet February-1992 Clonazepam 0.5mg/1.0mg/2.0mg Tablet 25-1-1995 Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg 08-07-10 Clonazepam IR 0.5mg/0.5mg+ Paroxetine CR 12.5/25mg Capsule 07-08-2010 Clonidin Hcl 100mcg Tablet/Capsule July-1975 (Bulk) March-1981 Clonidine Hcl February-1975 Clonidine Hcl 0.15mg Tablet July-1975 Clonidine HCl 0.1mg/0.2mg + Chlorthalidone 15mg/15mg Tablet Dec-77 Clonidine HCl 100mcg + HCTZ 20mg Tablet/Capsule Jul-75 Clonidine Hcl 150mcg/ml Injection June-1976 Clopamide 20mg Tablet July-1979 Clopedogrel bisulphate eq. to Clopidogrel 75mg + Aspirin IP (as enteric coated tablets) 27.11.2002 75mg/150mg capsules Clopidogrel 22.02.2001

PHARMADOCX CONSULTANT 27 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Clopidogrel 300mg Tablet (addl. Strength) 02.09.08 Clopidogrel Bisulphate eq. to Clopidogrel 75mg 15.03.16 Aspirin 100mg tablets (additional strength) Clopidol (For Veterinary) January-1972 Clorexolone 10mg/25mg Tablet October-1968 Closantel 15% Oral Solution (For Veterinary) 3-10-1994 Closantel Injection100mg/ ml (forverterinary use.) 05.02.09 Clostebol Acetate September-1986 Clostimethate Sodium of 1,00,000IU Injection 31.01.08 Clostridium botulinum toxin type A - Hemagglutinin complex 100 units Human Serum Albumium 13.01.1994 0.5mg+ NaCl 0.9 mg Clostridium Botulinum Toxin Type A Hemagglutinin Complex 100 units. Human Serum Albumin 13-1-1994 0.5mg + NaCl 0.9mg per vial (i.m) Injection Clostridium Botulinum Toxin Type-A Injection 03-06-2011 100Units/Vial (Additional Indication) Clostridium Botulinum type-A toxin haemagglutinin complex (Additional Indication) 22.04.08 Clotrimazole May-1975 Clotrimazole 0.1gm Vaginal Tablet June-1975 Clotrimazole 1gm/100gm Cream June-1975 Clotrimazole IP 100mg Soft Gelatin Pessary 17-2-1998 Clotrimazole (10mg) + Methyl- prednisolone aceponate 1mg/gm of cream. 12-7-2007. Clotrimazole (10mg) + Methyl-prednisolone aceponate 1mg/gm of cream. 12-7-2007. Clotrimazole 10mg Lozenges 13-3-2000 Clotrimazole 1gm/100ml Cream Solution June-1975 Clottable protein 75-115mg + Trace of Fibronogen 70-110mg + Plasma Fibronectin 2- 9mg + 30.05.2000 Factor XIII 10-50 U2 + Plasminogen 40-120mcg + Aprotinin solution 300 KIU/ml3 per ml of reonstituted tissueol solution Cloxacillin August-1965 Cloxacillin Benzathine Intramammary Infusion 500mg (For Veterinary) October-1987 Cloxacillin sodium 200mg+Colistine sulphate 50000 units per 10 ml Intrammamary infusion (vet) 04.03.1998 25mg/100mg Uncoated Tablet 7-3-1995 Clozapine Tablet200mg (Addl. Strength) 19.08.2009 Cobalt glutamate + Copper Glycinate Aug-61 Cohorton Ointment May-1965 Colesevelam Hydrochloride Tablets 625mg & Sachets for oral suspension 3.75gm/1.875gm. 29.08.2012 Colfosceril Palmitate 108mg per vial Injection 1-12-1993 Coligen (Escherichia coli bacterin) Vaccine (For Veterinary) June-1990 Colistimethate Sodium powder for solution for inhalation 500000IU/1000000IU/2000000I U 28.7.2009 Colistimethate Sodium powder for solution for injection/infusion 500000IU and 2000000IU 20.7.2009 (additional Strength) Colistin 1.5MU/0.25MU Tablet & 1MU Vial June-1962 Colistin Sulphate (300000 IU) 0.154gm + Pectin 0.196gm + Kaolin 2.625gm per 30ml suspension Sep-69 Collagen Fleece 2-3-2000 Collagen with Gentamicin Implant 6-5-1998 Collagenase 250 units per gm Ointment 5-5-1994 Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg) 02.04.07 Comb kit of two capsule of Azaranari 150mg each + 1 tablet of Ritonavir 100mg) 02.04.07 Comb pack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 20.04.07 500mg/100ml) Combi kit of 5 tablets each I) Pseudoephedrine HCl 120mg ER+Cetirizine HCl 5.0mg (orange 01.08.2004 tablet) & II) Pseudoephedrine Hcl ER 120mg +Tripolidine2.5mg (Blue tablets) Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 01.05.07 500mg calcium each Combi pack of 1 tablet of Residronate sodium (35mg) + 6 tablet of calcium carbonate equivalent to 01.05.07 500mg calcium each

PHARMADOCX CONSULTANT 28 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 23.01.08 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol-250IU Combikit 4 tablets of Alendronate sodium trihydrate equivalent to Alendronic acid 70mg each + 24 23.01.08 tablets of Calcium carbonate 1250mg (equivalent to 500mg Calcium) + cholecalciferol-250IU Combikit of 10 ml of 0.05% & 15 ml of NaCl solution 2% 12.10.2001 Combikit of 1 capsule of Glucosamine Sulphate 500mg & Chondroitin Sulphate capsule 400mg 30.09.2002 Combikit of 1 tablet of Efavirenz 600mg , 1 tablet of Lamivudine 300mg & 1 capsule of Didavosine 20.09.2004 (250 mg/400mg) (delayed Release) Combikit of 1 tablet of Pioglitazone HCl eq. to Pioglitazone-15mg & 2 Tablet of Metformin HCl 18.02.2002 500mg Combikit of 2 enteric coated tablet of Pantoprazole 40mg ,2 film coated tablet of Amoxycillin 15.10.1999 750mg & 2 film coated tablet of Tinidazole 500mg. Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz 07-06-2005 (600mg) Combikit of 2 tablet of Lamivudine (150mg) + Zidovudine (300mg) each and 1 tablet of Egavirenz 06-07-2005 (600mg) Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz 07-06-2005 (600mg) Combikit of 2 tablet of Stavudine (40mg) + Lamivudine (150mg) each & 1 tablet of Efavirenz 06-07-2005 (600mg) Combikit of 2 tablets of Stavudine 30mg/40mg 22.11.2004 + Lamuvidine 150mg/150mg & 1 tablets of Nevirapine 200mg. Combikit of one film coated tablet of Risendronate Sodium 35mg & six film coated tablet of 05.07.2007 Calcium Carbonate 1250 mg (Eq. to 500mg Cl) Combikit of HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 19-01-2006 0.5mg (10no.) Combikit of Tamsulosin HCl 0.4mg M.R capsule (10 no.) & Dutasteride Soft Gelatin Capsule 19-01-2006 0.5mg (10no.) Combination Vaccine DPT + Hi-b 1-6-2000 Combination of L Oxethazaine + Aluminium hydroxide + Magnesium Hydroxide Jun-66 Combination of Lactic Acid Bacteria (VSL#3) Sachet 8.4.13 Combipack of 1 vial of Ifosfamide 1gm & Mesna 100mg/ml 30.07.1999 Combipack (Triple chambered bag) of amino acid+electrolytes; Dextrose 15% / 30% IV fat 01.11.2003 emulsion Combipack containing : 1 capsule of Omeprazole 20mg cap, 1 tablet of Amoxycillin 750mg & 1 09.09.1997 tablet of Tinidazole 500 mg Combipack containing : 1 capsule of Omeprazole 20mg cap, 1 tablet of Clarithromycin 250mg tab 09.09.1997 & 1 tablet of Tinidazole 500mg tab II. Omeprazole 20mg cap+Amoxycillin 750mg tab+Tinidazole 500 mg Combipack of 21 tablets of FDC of Ethinylestradiol IP 0.03 mg + Levonorgestrel IP 0.15 mg 13.10.10 and 7 tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of Ferrous iron) Combipack of Desogestral and Ethinyl Estradiol 29.05.2000 Combipack of 1 bottle of ciprofloxacin Injection (200mg/100ml) & 1 bottle of Ornidazole injection 20.04.07 500mg/100ml) Combipack of 1 tab of Estradiol 2mg & 1 tab of Estradiol 2mg+ Dydrogestrone 10mg 01.02.2000 Combipack of 1 tablet of Fluconazole 150mg , 1 film coated tablet of Azithormycin dihydrate eq. to 07.06.1999 Azithromycin 1gm & 2 fillm caoted tablet of Secnidazole 1gm Combipack of 1 tablet of Gestodene 60mcg+Ethinyl estradiol 15mcg & 24 tablets + 4 dummy 17.02.2000 tablets per pack Combipack of 12 Artesunate – 50mg tablets & 6 Mefloquin- 250mg tablets 12.6.07 Combipack of 12 Artesunate –50mg tablets & 6 Mefloquin-250mg tablets 12.6.07 Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine 01-08-2007. (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength) Combipack of 12 tablet of Artesunate (50mg) each + 3 tablet of each containing Sulfadoxine 01-08-2007. (500mg) + Pyrmethamine (25mg) Tablet. (Addl. Strength) Combipack of 2 capsule of Omeprazole 20mg , 2 Tablets of Clarithromycin 500mg & 4 capsule of 01.10.2002 Amoxycillin 500mg.

PHARMADOCX CONSULTANT 29 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Combipack of 21 active tablet contains Noretihsterone acetate 1mg + Ethinyl oestradioal 30mcg & 7 Oct-75 Haematinic tablets contain Ferrous Fumarate 60mg Combipack of 21 tablet of Quinin sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 100mg 10-8-2006 each) Combipack of 21 tablet of Quinine sulphate 600mg each & 8 capsule of Doxycycline (as Hcl) 08-10-2006 100mg each Combipack of 21 tablets of FDC of Ethinylestradiol IP 0.03 mg + 13.10.10 Levonorgestrel IP 0.15 mg and 7 tablets of Ferrous Fumarate IP 75mg (Eq. to 24.375 mg of Ferrous iron) combipack of 22 tablets of Lynestrenol 1mg + Ethynyloestradiol 50mcg & 6 placebo tablets of Jun-80 Ferrous Fumerate 60mg combipack of 28 Tablets of Cyproteron acetate 2mg & 7 Tablets of Ethinyl Estradiol 0.035mg. 20.02.2003 Combipack of 7 blue tab of Desogestrel 0.025mg+ethinyl estradiol 0.04mg & 15 white tab of 29.05.2000 Desogestrel 0.125mg+ethiyl estradiol 0.03mg Combipack of artesunate table t and FDC Tablet 15.7.2009 of sulphadoxine + pyrimethamine Composition: A. combipack of 1 stip of 3 tablets ofartesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg+ pyrimethamine 6.25 mg B. combipack of 1 stip of 3 tablets ofartesunate 50 mg and 1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg C. combipack of 1 stip of 3 tablets ofartesunate 100 mg and 1 strip of 2 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D.combipack of 1 stip of 3 tablets ofartesunate 200 mg and 1 strip of 3 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg. Combipack of artesunate tablet and FDC Tablet of sulphadoxine + pyrimethamine Composition:A. 15.7.2009 combipa ck of 1 stip of 3 tablets ofartesunate 25 mg and 1 strip of 1 tablet of sulphadoxine 125mg+ pyrimethamine 6.25mg B. combipack of 1 stip of 3 tablets ofartesunate 50 mg and1 strip of 1 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg C. Combipack of 1 stip of 3 tablets ofartesunate 100 mg and 1 strip of 2 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg D. combipack of 1 stip of 3 tablets ofartesunate 200 mg and 1 strip of 3 tablet of sulphadoxine 500mg+ pyrimethamine 25 mg. Combipack of Estradiol + Dydrogesterone : 1. Each pack contains 28 tablets of Estradiol 1 mg 14.11.2006 + Dydrogesterone 5 mg. 2. Each combipack contains 28 tablet: each of 14 tablets contains estradiol 1mg & other each of 14 tablets contain estradiol 1 mg + Dydrogesterone 10 mg. Combipack of FDC Gestodene 60mg + Ethinyl Estradiol 0.15mg & 4 Dummy Tablets 18.07.2000 Combipack of one bottle of (1000ml) contains: Amino acid 7% w/v+glucose 10% with electroytes 28.08.2000 injectable filled upto 750ml & one bottle fat emulsion 20% w/v in 250ml combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack) 10-10-2006 combipack of one cap. Of aprepitant .125mg & two cap. Of aprepitant 80mg each (combipack) 10-10-2006 Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl 10-10-2007. (100mg) each Combipack of two tablet of chloroquine phosphate (250mg) each + 14 tablet of Proguanil HCl 10-10-2007. (100mg) each Combipack 04.06.14 Each strip contains- A. Sitagliptin Phosphate film coated tablets Each film coated tablet contains: sitagliptin Phosphate monohydrate Eq to 100 mg of sitagliptin B. Metformin Hydrochloride Sustained release Tablet IP. Each uncoated tablet contains: 1000 mg of metformin Hydrochloride IP (additional strength) Comipack of Ibandronic acid 150mg + Calcium carbonate 500mg + Calcitriol 0.25mg + Zinc 05.03.2009 sulphate 20mg Complex 15 Cream 10-1-1997

PHARMADOCX CONSULTANT 30 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Conivaptan Hydrochloride Injection 20mg/4ml. 21.08.2012 Conjugated Estrogens 0.3/0.45mg + Medroxy Progesterone Acetate 1.5/1.5mg Tablets 26.10.2004 Conjugated Estrogens 0.625mg/0.625mg + MPA 2.5mg/5mg sugar coated tablet 13.09.1999 Coseal Surgical Sealent 2/4/8ml (Addl. Indication) 06-02-2010 Coumaphos 3% + Propoxur 2% + Sulphanilamide 5% powder for vet 23.04.2002 Coumarin Tablet July-1995 Cream contains: 02.01.15 Gamma benzene Hexachloride IP 0.10% w/w Proflavin Hemisulphate 0.10%w/w Cetrimide IP 0.45 % w/w (veterinary product) Creatine Phosphate 500mg/1gm per vial Injection 20-1-1997 Crizotinib hard gelatin Capsules 200mg/250mg 16.12.11 Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syrings 28-05-2010 Cross linked Hyaluronic Acid 24mg + Lidocaine 3mg Pre-filled syrings 28-05-2010 Cumophos 50% (For Veterinary) 5-7-1993 Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 07-06-2010 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg Tablet Cyanocobalamin 15mcg+Chromium Picolinate USP 250mcg+Folic Acid USP 1500 06-07-10 mcg+Nicotinamlide IP100 mg+Pyridoxine 3mg +Selenius Acid USP 100mcg+Zinc Sulfate Monohydrate USP 61.8 mg eq. to 22.5 mg Cyanocobalamine + Zinc tannic acid complex Jan-61 Cyclandelate October-1972 Cyclandelate 200mg Capsule July-1977 Cyclandelate 200mg Tablet February-1973 Cyclobenzaprine 7.5mg tablets (Additional Strength) 18.08.08 Cyclobenzaprine HCl ER Capsule 15/30mg 17.12.08 CyclobenzaprineHcl. Tablets 5mg/10mg 31.01.08 Cyclopenthiazide 0.5mg Tablet February-1962 Cyclopentolate Hcl BP 0.5%/1%/2% Ophthalmic Solution March-1990 Cyclosporin 10mg Capsule 27-6-2000 Cyclosporin Eye drops (0.1%) (addl. Strength) 2-6-2006 Cyclosporin Oral Solution/ Concentrate for Injection/Capsule June-1988 Cypermethrin 1.0% w/w + Miconazole Nitrate IP 2.0%w/w shampoo for topical application to hair 30.04.15 coat. (veterinary product) Cypermethrin High Cis 100gm per litre (For Veterinary) 16-9-1996 Cyproheptadine Hcl 4mg Tablet January-1973 Cyproheptadine Hcl. (4mg) Tablet & (2mg/ml) Syrup April-1962 Cyproterone Tablet 10-06-2003 Cytarabine Injection June-1980 Cytarabine Injection 100mg Additional Packsize (20ml) 10-02-2010 D - norgestrel 0.25mg + Ethinyl estradiol 0.05mg Tablet Apr-71 Dabigatran Etexilate Mesilate hard gelatin capsule 75/110/150mg 17.11.14 (Additional Indication) Dabigatran Etexilate( as Mesilate) hard gelatin Capsules 75mg/110mg/150mg 12.12.11 DabigatranEtexilateMesilateeq to DabigatranEtexilate 75mg/110mg/150mg 11.2.13 Dabrafenib 50mg/75mg Capsules (Dabrafenib Mesylate) 18.01.17 Daclatasvir Dihydrochloride bulk & Tablet 30mg/60mg 14.12.2015 Daclatasvir Tablet 30 mg 24.05.2017 Daclatasvir Tablet 60 mg 24.05.2017 Daclizumab 25mg/5ml vial Solution for Infusion 12-10-2000 Dalteparin Sodium Injection(Additional Indication) 30.01.08 Danazol January-1982 Danazol 100mg/200mg Capsule March-1982 Danofloxacin Mesylate 25mg per ml Injection (For Veterinary) 12-8-1995 Dapagliflozin Tablet 5mg/10mg 25.02.2015 Dapoxetine ( as Hydrochloride) 13.11.10 Tablets …30mg/60mg

PHARMADOCX CONSULTANT 31 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Daptomycin powder for concentrate for solution for infusion (350mg/500mg per vial) 28.01.08 Darifenacin (as hydrobromide) 7.5mg/15mg ER tablets 31.01.08 Darunavir Ethanolate eq. to Darunavir 600mg Ritonavir IP 100mg, tablets Each film coated 16.05.2017 tablet contains: Darunavir Ethanolate 17.08.2017 eq. to Darunavir………400mg Ritonavir IP …………..50mg (Additional strength) Each film coated tablet contains: Darunavir Ethanolate 17.08.2017 eq. to Darunavir………400mg Ritonavir IP …………..50mg (Additional strength) Each film coated tablet contains: Darunavir(as ethanolate) Tablet 300mg 19.03.09 DarunavirEthanolate 800mg film coated tablet (Additional Strength) 04.05.2016 Dasatinib 20mg/50mg/70mg (Additional 16.03.11 Indication) Dasatinib tablet 20mg/50mg/70mg tablet 30-08-06 Dasatinib Tablets 100mg (addl. Strength) 10.07.2009 Daunorubicin December-1972 Decapeptide 22.10.2001 Decitabine Injection 30mg/vial (Additional pack size) 13.02.15 Decitabine lyophilised powder for injection 50mg/20ml vial (additional indication) 09.04.2014 Decitabine Lyophilized powder for injection 50mg/20ml vial 25.04.2009 Deferasirox 100mg dis.tablet(addl. strength) 28.11.07 Deferasirox dispersible tablet (400mg) (addl. Strength). 17-08-2007. Deferasirox Dispersible tablet 100/400mg (Additional indication) 26.9.2014 Deferasirox dispersible tablet 125/250/500mg. 10-7-2006 Deferasirox film coated tablet 90mg/180mg/360mg (Additional strength) 05.05.2016 Deferasirox Tablet for Oral Suspension (Additional Sosage Form) 14.12.2010 Deflazacort (1,6,30mg) tablet 02-11-2004 Deflazacort Oral Suspension (6mg/5ml) (New dosage form) 15-06-2007. Deflazacort Tablet 18mg (Additional Strength) 30-01-2010 Deflazocort 24mg tablets (Additional strength) 14.05.08 Deflazocort oral suspension (6mg/5ml) (new Dosage Form) 15.06.07 Degarelix for Injection 80mg / 120mg per vial 19.01.12 Dehydro-Emetine Ampoule April-1963 Delamanid 50 mg tablet 02.08.2017 Deltamethrin (0.50% m/v) and Piperonyl Butoxide (2.0% m/v) per ml Pour–On Solution 29.10.2009 Deltamethrine 12.5gm each litre (For Veterinary) June-1990 Deoxyribonuclease 250000 & 100000 Units Vials January-1968 Depo-Provera Injection 18-11-1993 Dequalinium Acetate November-1961 Desamino-oxytocin December-1974 Desflurane liquid for inhalation (240mg/bottle). 22-02-2006 Desloratadine 2.5mg/5mg+ Pseudoephodrine (SR) 120mg/180mg tablet 01.01.2004 Desloratadine (2.5mg) + Ambroxol (30mg) + Guiphenasine (50mg) + Menthol 1mg/5ml Syrup 03-02-2005 Desloratadine (2.5mg) + Ambroxol (30mg) + Guiphenasine (50mg) + Menthol 1mg/5ml Syrup 02-03-2005 Desloratidine 30.10.2001 Desmopressin Acetate tablet 0.1/0.2 mg 12.12.08 Desmopressin Intranasal Solution/Nasal Solution/Nasal Spray/Injection August-1989 Desmoprission lyophilisate Oral tablets 60mcg/120mcg/240mcg per tablets 08.05.08 Desogestrel January-1989 Desogestrel 0.15 mg+Ethinylestradiol 0.03 mg each tablets Nov-83

PHARMADOCX CONSULTANT 32 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Desogestrel 0.15mg and 06.07.2017 Ethinylestradiol 0.03 mg (of 21 tablets ) Each uncoated tablets contains: Desogestrel BP 0.15mg Ethinylestradiol IP 0.03mg with 7 inert tablets (Additional strength) Each combipack of 28 tablets contains: Desonide 0.05% Cream 7-3-1997 Desoximetasone July-1975 Desoximetasone 0.05% Ointment July-1979 Desoximetasone 2.5mg/gm Ointment September-1975 (as Succinate) ER Tablets 50mg/100mg 18.7.2009 Dexamethasone Sodium Metasulphobenzoate Injection April-1962 Dexamethasone Trimethyl Acetate Ointment (Ophth.) August-1961 Dexamethasone 0.125mg + Indomethacin 25mg Capsule Nov-71 Dexamethasone Intravitreal implant 0.7mg (Additional Indication) 12-10-15 Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system) 16-01-2010 Dexamethasone Intravitreal Implant 0.7mg (in solid polymer drug delivery system) 20.2.13 Dexarazoxane Injection 26.02.2002 Dexchlorpheniramine Maleate 2mg Tablet July-1976 Hcl 15mg Capsule 22-6-1992 Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet 08-10-2006 Dexibuprofen 200mg/300mg +Paracetamol 500mg tablet 10-8-2006 Dexibuprofen Suspension 50mg/5ml 14.08.08 Dexibuprofen Tablet (200mg/300mg/400mg) 6-2-2006 Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets 20-05-2010 Dexketoprofen (as Trometamol ) tablets 12.5mg/25mg 28.03.08 Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets 18.05.2009 Dexketoprofen 12.5 mg/25 mg + Paracetamol 500 mg film coated tablets 18.05.2009 Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection 28.04.11 Dexketoprofen 50mg + Dicyclomine 20mg per 2ml Injection 28.04.11 Dexketoprofen Trometamol 25mg + Thiocolchicoside 4mg tablets 20-05-2010 Dexketoprofen Trometamol ER Tablet 50 mg (Additional Strength) 21.02.11 Dexketoprofen Trometamol Gel 12.5mg/gm 13.10.2009 Dexketoprofen Trometamol Injection 50mg/2ml 22.10.2009 Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w +Methyl Salicylate 10%w/w 07-06-2010 (12.5mg) Gel Dexketoprofen1.25% w/w +Linseed Oil 3.0%w/w +Menthol 5%w/w 06-07-10 +Methyl Salicylate 10%w/w (12.5mg) Dexlansoprazole Delayed Release Capsule 30/60mg & Bulk 16.01.17 ( as HCl) 100mcg /ml Injection 29.05.09 Dexmedetomidine HCl Injection (Additional Indication) 14.11.2009 Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules 09.06.08 Dexrabeprazole 10mg (EC) + Domperidone 30mg SR Capsules 09.06.08 Dexrabeprazole Sodium E. coated tablet 5mg/10mg. 13-06-2007. Dexrabeprazole sodium Enteric Coated tablet 5mg/10mg 13.06.07 Dextranomer 4gm/6gm Sachet September-1985 Dextranomer Soluidine Complex Beads August-1986 Dextrochlorpheniramine Maleate (2mg) Tablet & (2mg/5ml) Syrup February-1969 Dextrometharpahan HBr- 10mg+Chlorphenaramine maleate- 2mg /5ml syrup. 12.11.07 Dextrometharpahan HBr- 10mg+Chlorphenaramine maleate-2mg /5ml syrup. 12.11.07 Dextromethorphan Extended Release Oral Suspension 30 mg per 5 ml 17.01.11 Dextromethorphan Hydrobromide Extended Release suspension 30mg/5ml (Additional Dosage 01.08.2013. Form) Dextromethorphan Orodispersible strip 5.5mg/11mg 28.01.08

PHARMADOCX CONSULTANT 33 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Dextrose IP eq. to dextrose anhydrous 453.0gm+Nacl IP 5.67gm water for injection q.s.Triple 25.09.2001 Chamber bags for peritoneal dialysis solution :Compartment A)[ 61 ml] each 1000ml Compartment B) [104 ml]Dextrose IP eq. to dextrose anhydrous 453.0gm+Nacl IP 5.67gm water for injection q.s. Compartment C) [1969ml] Nacl IP 5.67gm+CaCl 2 IP 0.279gm+MgCl2 IP 0.165gm+Sodium lactate solution BP eq. to sodium lactate 4.259 gm water for injection, each 1000 ml water for injection q.s. Di iodochlorhydroxyquinoline 300mg + Berberine Hcl 40mg + Homatropine methylbromide 0.8mg Jan-70 tablet Diacerein 12-03-2004 Diacerein Modified Release Capsule 100mg 20.11.2009 Diacerin 50mg + Aceclofenac 100mg tablets 11.04.08 Diacerin 50mg + Aceclofenac 100mg tablets 11.04.08 Diacerin 50mg + Glucosamine 1500mg Tablets 09.04.2008 Diacerin 50mg + Glucosamine sulphate 500mg tablets. 21.04.08 Diacerin 50mg + Glucosamine sulphate 500mg tablets. 21.04.08 Diacerin 50mg + MSM 250mg + Glucosamine 750mg Tablet 01.06.2009 Diazepam 2.5mg + Sorbide Dihitrate 10mg Tablet Dec-79 Diazepam 5mg + Paracetamol 500mg tablet Oct-77 Diazepam 5mg/ml Injection December-1977 Diazepam IP 2mg/4mg per ml Rectal Solution 17-6-1999 Diazepam Tablet & Injection March-1966 Diazinon 20% w/w (For Veterinary) April-1990 Diazinon Flea Drops Spot on Dogs 30.0% w/w 11.11.11 Diazoxide August-1978 Dibazole April-1965 Dichlorphenamide 50mg Tablet January-1964 Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules 21.10.08 Diclofenac Diethyl Ammonium 174mg Plaster of 10cm x 15cm dimension 21-5-1997 Diclofenac Diethylamine 1.16% w/w eq. to Diclofenac Sodium 1% w/w + (Methysalicylate 09.06.2008 , Linseed Oil, Menthol) Diclofenac Sodium 25mg/ml Injection (For Veterinary) 14-7-1993 Diclofenac Sodium USP 25mg/50mg Tablet September-1985 Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule 31.05.11 Diclofenac (as EC Tablets) 25mg + Paracetamol 325 mg Capsule 31.05.11 Diclofenac + Thiocolchicoside (50 mg + 4 mg) Capsules (additional strength) 24.12.08 Diclofenac + Thiocolchicoside (50 mg+4 mg) Capsules 24.12.08 Diclofenac + Thiocolchicoside (50mg (EC) + 8mg) Capsules 21.10.08 Diclofenac 100mg (EC) + Thiocolchicoside 8mg Capsule 06.07.2010 Diclofenac 10mg + Serratiopeptidase 10/15mg tab & Cap. On 20/8/08 24.01.2008 Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet 24.01.08 Diclofenac 50mg + Chlorzoxazone500mg Tablets 16-03-2010 Diclofenac 50mg + Chlorzoxazone500mg Tablets 16-03-2010 Diclofenac 50mg + Serratiopeptidase 10mg enteric coated tablet 24.01.08 Diclofenac Colestyramine 145.6 mg corresponding to 75mg Diclofenac Sodium Capsules. 19.05.11 Diclofenac Colestyramine 145.6mg Capsule Corresponding to Diclofenac Sodium 75mg (Additional 25.2.13 Indication) Diclofenac Diethyl amine transdermal patch 100 mg/37.5 sq cm (Additional Strength) 4.12.2009 Diclofenac Diethylamine BP 2.32 % w/v Eq to Diclofenac Sodium 2.00 % w/v + Methyl Salicylate 01.01.2013 IP 10.00% w/v + Menthol 5.00 % w/v + Absolute Alcohol IP 10.00 % v/v Topical Solution (Additional Strength) Diclofenac Diethylamine BP 2.32 % w/v Eq to Diclofenac Sodium 2.00 % w/v + Methyl Salicylate 01.01.2013 IP 10.00% w/v + Menthol 5.00 % w/v + Absolute Alcohol IP 10.00 % v/v Topical Solution (Additional Strength) Diclofenac Diethylamine BP 4.64 % w/v Eq. to Diclofenac Sodium IP 4.00 % + Absolute Alcohol 21.12.12 IP 10.00 % v/v Topical Solution Diclofenac Potassium 50mg Sugar Coated Tablet 18-3-1994

PHARMADOCX CONSULTANT 34 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules 08.04.08 (Additional Strength) Diclofenac Potassium 50mg + Serratiopeptidase (as enteric coated pellets) 15mg capsules 08.04.08 (Additional Strength) Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg Capsules 24.08.11 Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. 28-02-2006 Diclofenac Sodium (75/50mg) as (E.C) + Misoprostol 200mcg. 28-02-2006 Diclofenac Sodium (75mg/ml) Injection (addl. Strength). 30-07-2007. Diclofenac sodium (SR) 100mg + Eperisone Hydrochloride (SR) 150mg Capsules 24.08.11 Diclofenac Sodium 0.1% (1mg/ml) Ophthalmic Solution Sterile 27-1-1995 Diclofenac Sodium 100mg (Adults) & 12.5mg (Children) Suppository 26-9-1997 Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) Capsules 31.01.08 Diclofenac Sodium 100mg (SR Pellets) + Rabeprazole Sodium 20mg (E.C Pellets) Capsules 31.01.08 Diclofenac Sodium 1gm Gel March-1991 Diclofenac Sodium 1mg + Gentamycin Sodium 3mg per ml 26.03.1999 Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection 28.01.08 Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets 02.06.08 Diclofenac Sodium 50mg + Codeine Phosphate 50mg tablets 02.06.08 Diclofenac sodium 50mg + Dicyclomine HCl 20mg per ml of injection 28.01.08 Diclofenac Sodium 50mg + Paracetamol 500mg tablets 30.01.08 Diclofenac Sodium 50mg + Paracetamol 500mg tablets 30.01.08 Diclofenac Sodium 50mg Dispersible Tablet 30-9-1993 Diclofenac Sodium 75mg/100mg Sustained Release Tablet January-1988 Diclofenac Sodium 75mg/3ml ampoule Injection June-1987 Diclofenac Sodium Injection 75mg/2ml 4.12.12 Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as sustained release 15.11.11 pellets) 16mg Capsule. (New Dosage Form) Diclofenac Sodium IP (as sustained release Pellets) 100mg + Thiocolchicoside (as 15.11.11 sustained release pellets) 16mg Capsule. (New Dosage Form) Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP (Tablet) 50mg Hard 06.01.12 Gelatin Capsules. (New Dosage Form) Diclofenac Sodium IP (Enteric coated granules) 50mg + Eperisone Hcl IP (Tablet) 50mg Hard 06.01.12 Gelatin Capsules. (New Dosage Form) Diclofenac sodium SR Tablet 150 mg 26-03-2010 Diclofenac Sodium Sustained Release Tablet (Two layered tablets) 150mg. 20.12.13 Each tablet contains Diclofenac Sodium IP-125 mg Slow Release, Diclofenac Sodium IP-25 mg Immediate Release(Additional Dosage Form) Diclofenac Transdermal Patch (200 mg/75 cm2) 06-10-2004 Diclofenac Transdermal patch 100 mg/50 Cm2 10-08-2004 Dicloxacillin July-1978 Dicloxocillin Sodium 62.5mg Oral Solution September-1979 Dicloxocillin Sodium 125mg/250mg Capsule August-1979 Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + 05-03-2010 Simethicone 20mg per 5ml suspension. Dicyclomine2.5mg + Dried Aluminimum Hydroxide200mg + Light Magnesium Oxide100mg + 03-05-2010 Simethicone 20mg per 5ml suspension. Didanosine 25mg/50mg/100mg Chewable Tablet 15-11-2000 Didanosine Powder for oral solution (2gm/4gm per bottles) 26-08-2005 Dienogest 2mg Tablets 09.03.2017 Diethylamine Salicylate 10% w/w Cream March-1978 Diethylamine Salicylate 10mg + Nopoxamine 1gm per 100gm ointment Mar-80

PHARMADOCX CONSULTANT 35 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Diflorasone Diacetate Cream (0.5mg/gm) 08-02-2005 Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops 22.09.11 Difluprednate 0.05% w/v + Moxifloxacin 0.5% w/v Eye Drops 22.09.11 Difluprednate Opthalmic Emulsion 0.05% w/v 30-03-2010 Dihydrotestesterone Gel 25-4-1994 Dihydroxy acetate 15%w/v + Alcohol 95% - 45%w/v lotion Oct-71 Dilazep Dihydrochloride 50mg Tablet November-1979 Diltiazam Hcl 90mg/120mg SR Tablet July-1989 Diltiazam Hcl 30mg/60mg MR Tablet July-1989 Diltiazam Hcl eq. to 30mg/60mg of Diltiazam Tablet July-1987 Diltiazem Hcl 5mg/ml Injection 16-5-1994 Diltiazem Hcl. 2% gel 07.02.07 Dimethindene MSaleate Tablet January-1965 Dimethothiazine 20mg Tablet October-1969 Dimethyl Fumarate delayed release 120 mg/240 mg capsule 27 08 14 Dimethyl polysiloxone 100mg + Enzyme concentrate Aspergilluss oryzae 120mg + Protease 126 Aug-78 units + Cellulase 185 units + Hemicellulose 64 units + Amylase 1.3 units + papaverine HCl 25mg Capsule Dimethylpolysiloxane Cream (Tubes of 75g & Jar of 40g) May-1969 Dimetridazole (For Veterinary Use) August-1975 Diminazene Diaceturate 70 mg+ Phenazone BP 375 mg + chlorocresol IP 0.1% w/v 13.02.15 Injectable dosing form (veterinary product) Each ml contains: Dinoprost 5mg/ml Injection (For Veterinary) May-1986 Dinoprostone (PGE2) 0.5mg Tablet February-1990 Dioctyl Sodium Sulfosuccinate USP Ear Drops5% September-1979 Diphenhydramine (as methyl sulpho methylate / methyl sulphate) 60mg Tablet & 480mg/100ml September-1961 Syrup Diphenoxylate HCl 2.5mg + Atropine Sulphate 0.025mg tablet Jul-69 Diphenoxylate Hcl. May-1969 Diphenoxylate Hcl. (Bulk) July-1969 Diphenylpyraline Hydrochloride 5mg Capsule April-1969 Dipiprolate 40mg Dragee March-1964 Dipivefrin Hcl USP 0.1% Ophthalmic Solution 16-5-1996 Diptheria+Tetanus Toxoid + Pertussis vaccine adsorbed and Haemophilu b CRM 197 Conjugate 12.10.1999 vaccine Dipyridamole (12.5mg) Tablet & (2ml of 10mg) Ampoule April-1964 Disodium Cromoglycate 2% Nasal Drops September-1976 Disodium Pamidronate Injection 21-2-1995 Disophenol Injection (Each c.c contains; disophenol - 45mg) (Veterinary use) April-1970 Disopyramide 100mg Capsule June-1977 Disopyramide Phosphate 100mg/5ml & 150mg/7.5ml Injection August-1983 Divalproax Sodium 17.01.2002 Divalproex Sodium E.R. Tablets (750mg/ 1000 mg) 24-06-2004 Divalproex Sodium Oral Solution 500mg/5ml (Additional Dosage Form) 23.12.13 DL - norgestrel 0.25mg + Ethinyl estradiol 0.05mg Tablet Sep-71 Dl - Norgestrel 0.5mg + Ethinyl estradiol 0.03mg Tablet Aug-74 DL- Norgestrel 300mcg + Ethinyl oestradiol 30mcg Tablet Oct-76 dl Norgestrel + 17 alpha hydroxy progesterone caproate + Norethisterone acetate + 17 alpha Jan-69 acetoxy progesterone dl-norgestrel 0.5mg + Ethinyl oestradiol 0.03mg April-1975

PHARMADOCX CONSULTANT 36 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download d-Norgestrel 0.03mg Coated Tablet April-1974 d-Norgestrel 0.03mg Tablet August-1974 Hcl 50mg/ml (Infusion Concentrate) Injection 4-10-1993 Docetaxel injection conc. 31.03.08 Docetaxel injection concentrate 80mg/2ml, 17.12.08 20mg/0.5ml (Additional Indication ) Docetaxel Trihydrate 80mg (2ml/vial) and 20mg (0.5ml/vial) with docetaxel solvent 6ml & 1.5ml 20-6-1996 Injection Dolutegravir 50 mg Tablet & Bulk (Dolutegravir Sodium) 07.11.2016 Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet 22-11-2005 Domperidone (10mg) + Activaed dimethicone (125mg) chewable tablet 22-11-2005 Domperidone 10mg Tablet November-1987 Domperidone 10mg/ml Oral Drops November-1987 Domperidone 1mg/ml Suspension November-1987 Domperidone 30mg Rectal Suppositories November-1987 Donepezil HCl 20.03.2001 Donepezil Hydrochloride Orodispersible Tablet 5mg/10mg 15.10.2009 Donepezil Sustained Release Tablet 23mg 03-06-2011 (Modified Dosage Form) HCl-80/160/320mg+Dextrose hydrous-5gm each 100ml contains injection 02.04.2002 Dopamine Hydrochloride 200mg/5ml Injection January-1980 Doramectin 1% Injectable Solution (For Veterinary) 3-10-2000 Doramectin 10mg/ml Injectible Solution 1% (For Veterinary) 17-10-1997 Doripenem (as monohydrate) Injection 250mg/500mg 16.02.09 Doripenem 500 mg powder for injection (Additional Indication) 10-08-10 Dorzolamide 03-10-2003 Dorzolamide (20 mg) + Timolol (5 mg) per ml Eye drops 01-09-2004 Dorzolamide 2% + Timolol 0.5% eye drops 28.08.2004 Dorzolamide Hydrochloride 2mg/ml + Timolol Maleate 5mg/ml ophthalmic solution (preservative 18.11.13 free formulation of the approved FDC)Each ml contains Dosulepin Hcl Tablet 25mg/75mg (Additional Indication) 08-04-2010 Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets 08.12.11 Dosulepine Hcl 50mg/75mg + Methylcobalamin 1500mcg/1500mcg Tablets 08.12.11 Dothiepin Hydrochloride May-1977 Doxapram Hydrochloride September-1977 Doxapram Hydrochloride 20mg/Vial November-1978 Doxazocin Mesylate 1mg/2mg/4mg Uncoated Tablet 11-3-1999 (as Mesylate) 4mg/8mg E.R. Tablet 30-11-2005 Hcl IP 5% w/w (eq. to Doxepin 4.4%) Cream 26-7-1997 Doxepin Hydrochloride July-1972 Doxepine Hydrochloride 10mg/25mg/50mg Tablet/Dragee/Capsule September-1972 Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules 29.05.08 Doxercalciferol (0.5/ 2.5mcg) Soft Gelatin Capsule (Additional Indication) 05.08.08 Doxercalciferol 0.5mcg/2.5mcg Soft Gelatin capsules 29.05.08 Doxifluridine Capsules 100mg/200mg 31.01.08 400 mg + Ambroxol 30 mg Tablets 23.12.2009 Doxofylline 400 mg + Ambroxol 30 mg Tablets 23.12.2009 Doxofylline ER tablets 400mg/800mg (addl. Strength) 12.03.08 Doxofylline MR Tablet 650 mg 11-03-2010

PHARMADOCX CONSULTANT 37 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Doxofylline Syrup (20mg/ml) 30-03-2006 Doxofylline Tablet (400mg) 8-2-2006 Doxophylline (SR) 400mg/800mg + 10mg/10mg Tablets 04-07-2010 Doxophylline (SR) 400mg/800mg + Montelukast 10mg/10mg Tablets 07-04-2010 Doxophylline- 400mg+Salbutamol(as sulphate)-2mg/4mg Tablets 29.11.07 Doxophylline injection-10mg /ml 31.12.07 Doxophylline-400mg+Salbutamol(as sulphate)- 2mg/4mg Tablets 29.11.07 Doxorubicin Hydrochloride 10mg per vial Injection July-1986 Doxorubicin Hcl 10mg/Vial September-1976 Doxorubicin HCl Pegylated Liposomal Injection (20/50MG) (Additional Indication) 23.08.08 Doxorubicin Hydrochloride 10mg/vial April-1975 Doxycycline (100mg) Capsule December-1967 & (10mg/ml) Syrup Doxycycline Hcl (eq. to Doxycycline base) 100mg Capsule December-1972 Doxycycline-100mg + L.bacillus spores-5 billion capsule pellets 12.11.07 Doxycycline-100mg +L.bacillus spores-5 billion 12.11.07 doxyphylline 2mg + Terbutaline 120mg per 5 ml Syrup 24.12.2008 Doxyphylline 400 mg + Terbutaline 5mg tablets 23.02.09 Doxyphylline 400 mg + Terbutaline 5mg tablets 23.02.09 D-Pencillamine 300mg Tablet July-1974 DPT ActHIB Vaccine January-1998 Dried Aluminium Hydroxide Gel IP 600mg +Magnesium Hydroxide IP 300mg 05.10.10 +Simethicone IP 25mg +Oxetacaine BP 10mg per 5ml suspension Dried Aluminium Hydroxide Gel IP 600mg +Magnesium Hydroxide IP 300mg +Simethicone IP 05.10.10 25mg +Oxetacaine BP 10mg per 5ml syrup Dried ferrous sulphate eq. to 50mg of elemental iron + Ascorbic acid 300mg + Sod. Bicarbomate Dec-73 84mg + Talcum 12mg capsule Dried Ferrous Sulphate IP 150mg (As Enteric Coated granules) eq. to Elemental Iron 45 mg 19.03.15 Folic acid 0.5 mg. (Additional dosage form) Each hard gelatin capsule contains: Dried IVY Leaf Extract (0.7gm/100ml) 15-09-2005 Dried yeast powder 250mg + Saccharomyces ceribial containig NLT 10 million living cells Capsule Jan-71

Dronedarone( as Hydrochloride) film coated tablet .... 400 mg. 08-04-2010 Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets 16-03-2010 Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) 05-11-2005 Drosperinone (3mg) + Ethinylestradiol (0.035mg tablet) 11-05-2005 Drosperinone + Ethinylestradiol tablets Same as approved 09.10.10 Drosperinone + Ethinylestradiol tablets Same as approved 09.10.10 Drosperinone 3mg + Ethinyl Estradiol0.02mg tablets 16-03-2010 Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) 28.03.08 Drospirenone 3mg + Ethinyl estradiol 0.02mg tablets (Additional Strength) 28.03.08 Drospirenone 3mg/3mg + Ethinyl Estradiol 0.02mg/0.03mg Tablets 28.03.2008 Drotaverine + Aceclofenac (80mg + 100mg) Tablets 15.09.08 Drotaverine + Aceclofenac (80mg +100mg) Tablets 15.09.08 Drotaverine 80mg + Aceclofenac 100mg Tablet 15.09.2008 Drotrecogin alpha 23.07.2002 Drug Name Date of Approval DTP + Hepatitis b Vaccine (Multidose vial of 5 ml containing 10 doses. 27.07.2000 D-trans Fentantyl Transdermal patches 5-4-2006 D-Trans Fentanyl Metrix system (12mcg/hr.) (Additional Strength) 07.01.08

PHARMADOCX CONSULTANT 38 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Duloxetine HCl (20,30,40mg) Tablet 02-11-2004 Duloxetine HCl (60mg) tablet (additional strength) 28-02-2005 Dutasteride 16-02-2004 Dybendal 0.5%w/w + Allantoin 0.2%w/w + Boric Acid 1%w/w + Menthol 0.08% v/w May-73 Each 10 ml (two teaspoonfuls) of oral dosage form(tonic) contains: 07.08.14 1.25 g of liver fraction derived from 31.25 g of fresh liver yeast Extract 0.4 g + Nicotinic acid IP 24 mg+ Ethanol (95%) IP 1 ml + Alcohol Content 9.4 % v/v (veterinary product) Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega- 14.05.2009 3 acidtriglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm+ Sodium oleate 0.30 gm + Alpha - tocopherol 0.20 gm +Ascorbypalmitate 0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion Each 1000 ml of emulsion contains: Medium chain triglycerides 100 gm + Soya oil 80 gm + Omega- 14.05.2009 3 acid triglycerides 20 gm + egg lecithin 12 gm + Glycerl 25 gm + Sodium oleate 0.30 gm + Alpha -tocopherol 0.20 gm + Ascorbypalmitate0.30 gm + Sodium hydroxide max. 0.06 gm + water for injection 784 gm emulsion for infusion Each 100ml contains: 10.07.2017 Ethanol IP……80% v/v Hydrogen Peroxide IP ……0.125% v/v Glycerol IP ……1.45% v/v Solution Each 5 ml (one teaspoonful) contains: Magnesium Hydroxide IP 98 mg Added as Magnesium 17.12.14 Hydroxide paste Aluminium Hydroxide 0.291 g (Added as Aluminium Hydroxide Paste) Eq to 0.380g of Dried Aluminium Hydroxide gel IP Oxetacaine BP 10 mg Liquid orals Each 5 ml Contains: 09.03.15 Aluminium hydroxide paste eq. to Dried Aluminium hydroxide gel IP 250mg + Magnesium hydroxide paste eq. to Magnesium hydroxide IP 250mg + Simethicone Emulsion USP eq. to Simethicone 50mg + Oxetacaine BP 10mg Each 5 ml of the suspension contains: 07.08.14 Levamisole HCl IP 112.5 mg eq to levamisole 95.45 mg + Oxyclozanide IP 150 mg + Anhydrous Copper Sulphate BP eq to elemental copper 1.25 mg + Zinc sulphate monohydrate USP eq to elemental Zinc 0.4 mg + Cobalt sulphate eq to elemental cobalt 0.15 mg (veterinary product) Each 5ml contains Codeine Phosphate 10mg + Triprolidine HCl 1.25mg syrup 18.02.2003 Each bowel preparatory kit contains: 11.02.11 One enteric coated tablet Biscodyl IP 5mg & One sachet of powder for reconstitution contains: Polyethylene glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm Each bowel preparatory kit contains:One sachet of powder for reconstitution contains: Polyethylene 11.02.11 glycol 3350NF: 210gm + Sodium Bicarbonate IP 2.86gm + Sodium Chloride IP 5.6gm + Potassium Chloride IP 0.74gm Each Combikit contains Part A - One film coated tablet of Tenofovir Disoproxil Fumarate 300mg 23.08.11 eq. to Tenofovir 245mg + Emtricitabine 200mg. Part B - One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg

PHARMADOCX CONSULTANT 39 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Each Combikit contains 23.08.11 Part A - One film coated tablet of Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir 245mg + Emtricitabine 200mg. Part B - One film coated tablet of Atazanavir sulphate eq. to Atazanavir 300mg + Ritonavir 100mg Each Combikit Contains: Part A: 09.05.2017 Two film coated tablets of Darunavir Ethanolate Each tablet contains: Darunavir Ethanolate eq. to Darunavir 600mg Part B: Two film coated tablets of Ritonavir Each film coated tablet contains: Ritonavir IP 100mg, tablets Each combikit contains: Part A: 21.12.2016 Two tablets of Lamivudine with Zidovudine Tablets IP Each Film coated tablets contains: Lamivudine IP 150mg Zidovudine IP 300mg Part B: One tablet of Atazanavir and Ritonavir Tablets Each film coated tablets contains: Atazanavir sulphate IP Eq. to Atazanavir 300mg Ritonavir IP 100mg Each Combikit Contains: 27.10.2016 Part A: Lamivudine and Tenofovir Disoproxil Fumarate Tablet IP (300mg/300mg) Each film coated tablets contains: Lamivudine IP 300mg Tenofovir Disoproxil Fumarate IP 300mg Eq. to Tenofovir Disoproxil 245mg Part B: Nevirapine Extended Release Tablets 400mg Each Extended Release Tablets Contains: Nevirapine 400mg Each Combikit contains: 12.06.2017 Part A: One film coated Tablet of Dolutegravir. Composition: Each film coated tablet contains: Dolutegravir sodium eq. to Dolutegravir 50mg Part B: One film coated tablet of Abacavir and Lamivudine IP. Composition: Each film coated tablet contains: Abacavir sulphate IP eq. to Abacavir 600 mg Lamivudine IP 300mg Each Combikit contains: 12.06.2017 Part A: One film coated tablet of Dolutegravir: Composition: Each film coated tablet contains: Dolutegravir sodium eq. to Dolutegravir 50mg Part B: One bilayered film coated tablet of Lamivudine and Tenofovir Disoproxil Fumarate IP Composition: Each bilayered film coated tablet contains: Lamivudine IP 300mg Tenofovir Disoproxil Fumarate IP 300mg

PHARMADOCX CONSULTANT 40 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Each combipack contains : A) One tablet of Risedronate Sodium - Each film coated tablet contains: 30.09.11 Risedronate Sodium (as Risedronate Sodium Hemi-Pentahydrate) - 35 mg B) Six Capsules of FDC of Calcitriol +Calcium carbonate + Zinc Each soft gelatin capsule contains : Calcitriol IP - 0.25mcg Calcium Carbonate IP - 500mg (eq. to elemental calcium 200mg) Zinc (as Zinc Sulphate USP) 7.5 mg Each Combipack contains Part (A) One Strip of FDC of Ramipril + Amlodipine Tablets;- Each 28.11.11 uncoated tablet contains Ramipril IP - 5mg, Amlodipine besylate IP eq to Amlodipine 5mg B) Each Film coated tablet contains ;- Atorvastatin Calcium IP eq to Atorvastatin 10mg/20mg. Each Combipack contains Part (A) One Strip 28.11.11 of FDC of Ramipril + Amlodipine Tablets;- Each uncoated tablet contains Ramipril IP - 5mg, Amlodipine besylate IP eq to Amlodipine 5mg B) Each Film coated tablet contains ;- Atorvastatin Calcium IP eq to Atorvastatin 10mg/20mg. Each Combipack contains: - 30.09.11 A) One tablet of Risedronate Sodium - Each film coated tablet contains: Risedronate Sodium (as Risedronate Sodium Hemi-Pentahydrate) - 35 mg B) Six Capsules of FDC of Calcitriol +Calcium carbonate + Zinc Each soft gelatin capsule contains : - Calcitriol IP - 0.25mcg Calcium Carbonate IP - 500mg (eq. to elemental calcium 200mg) Zinc (as Zinc Sulphate USP) 7.5 mg Each combipack contains: 13.02.15 1. One vial Containing: Amoxycillin Sodium IP Eq. to Amoxycillin 200mg/2000mg/3000mg + Sulbactam Sodium USP Eq. to Sulbactam 100mg/1000mg/1500mg 2. One ampoule of Sterile water for injection IP 5ml/15ml/15ml Each combipack contains: 01.04.14 21 pills of FDC of levonorgestrel + ethinylestradiol tablets IP: Each sugar coated tablet contains: Levonorgestrel IP 150 mcg + ethinylestradiol IP 30 mcg 7 pills of placebo/inert tablets Each combipack contains: 14.10.14 A. Each 5 ml of constituted suspension contains: 1. Amoxicillin Trihydarte IP eq to Amoxicillin 200 mg + Potassium Clavulanate IP eq to Clavulanic acid 28.5 mg 2. Amoxicillin Trihydarte IP eq to Amoxicillin 400 mg + Potassium Clavulanate IP eq to Clavulanic acid 57 mg B. One vial of purified water IP Each Vial contains: Purified water IP 30 ml (additional Pack) Each combipack contains: 03.04.14 One tablet of Tenofovir Disoproxil FumArate+ Emtricitabine IP Each film coated tablet contains: Tenofovir Disoproxil Fumarate IP 300 mg Emtricitabine IP 200 mg Two tablets of Nevirapine IP Each tablet contains: Nevirapine IP 200 mg Each Combipack of 21 tablets contains : A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each 27.07.11 sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : - Ferrous Fumarate 75mg eq. to 24.375mg of ferrous iron

PHARMADOCX CONSULTANT 41 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Each Combipack of 21 tablets contains : 27.07.11 A) FDC of Norgestrel & Ethinyl estradiol tablets IP Each sugar coated white tablet contains: Norgestrel 0.30mg & Ethinyl estradiol 0.03mg B) 7 tablets of Ferrous Fumarate: Each sugar coated tablet contains : - Ferrous Fumarate 75mg eq. to 24.375mg of ferrous iron Each Combipack of 28 Tablets contains : 30.06.2017 24 tablets of Drospirenone IP 3mg and Ethinylestradiol IP 0.02 mg Each uncoated tablets contains: Drospirenone IP 3mg Ethinylestradiol IP 0.02mg with 4 inert tablets Each combipack of 28 tablets contains: 06.07.2017 21 tablets of Desogestrel 0.15mg and Ethinylestradiol 0.03 mg Each uncoated tablets contains: Desogestrel BP 0.15mg Ethinylestradiol IP 0.03mg with 7 inert tablets (Additional strength) Each gm contains:- 15.03.2002 Capae Extract 0.1 gm+ Heparin Sodium I.P 50 IU + Allantoin B.P 0.01gm Gel Each gram contains: 24.11.2016 Tretinoin USP (As Microsphere) 0.4mg Clindamycin Phosphate USP Eq. to Clindamycin 10mg, Gel Each kit Contains: 05.03.15 1. 5 sachets of Oral Rehydration Salts (4.4 g each) Each sachet contains: Combikit of Dextrose Anhydrous IP 2.70g + Sodium Chloride IP 0.52g + Sodium Citrate IP 0.58g + Potassium Chloride IP 0.30g 2. 14 tablets of elemental zinc Each uncoated dispersible tablet contains: Zinc Sulphate monohydrate IP Eq. to elemental Zinc 20mg. Each ml contains Calamine 15% w/v + Zinc oxide 5% w/v + Bentonite 3% 08.05.2009 w/v+Glycerin 5%w/v + Sodium citrate 0.05 % w/v lotion Ebastine 28.09.2001 Eberconazole 1% w/w + Furate USP 0.1% w/w cream 13.10.10 Eberconazole 1% w/w + Mometasone Furate USP 0.1% w/w cream 13.10.10 Eberconazole cream (1%) 22.03.07 Econazole 1% Ophthalmic Ointment September-1985 Econazole Nitrate 150mg Vaginal Tablet December-1980 Econazole Nitrate 1% Cream December-1980 Edrophonium Chloride (10mg in 1cc) Ampoule October-1961 Efavirenz 06.06.2001 Efavirenz Oral Solution (30mg/ml) 25-08-2005 Eflornithine HCl Cream (139mg/gm) 22-03-2006 Efonidipine Hydrochloride Bulk & Tablets 10 mg/20mg/40mg 28.08.2017 Eicosapentaenoic acid (EPA) 180mg + Docoshexaenoic acid (DHA) 120mg Sep-89 Elemental iron (as carbonyl modified release) 45mg+Folic acid 1.5mg+ vitamin B12-15mcg film 19.04.2004 coated tablet Elemental Iron in a complex of Iron Polymaltose 50mg/ml Drops February-1977

PHARMADOCX CONSULTANT 42 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Eletriptan Hydrobromide Tablets 25.08.11 20mg/40mg Eliglustat 84mg Capsules 31.01.17 (Eliglustat Tartrate or Hemitartrate Salt) Eliglustat 84mg Capsules 02.03.2017 (Eliglustat Tartrate or Hemitartrate Salt) EltrmbopagOlamine 25mg and 50mg 14.09.2016 (Additional Indication) Eltrombopag (as Olamine) Tablets ...25mg / 50mg 16.10.10 Eltrombopag Olamine tablet 25/50mg (Additional Indication) 07.04.2014 Eltrombopagolamine 25 mg/50 mg tablets 02.03.2017 (Additional indication) Emphagliflozin Tablet 10mg/25mg 07.05.2015 Empty Hydroxy Propyl Methyl Celulose Capsules 11.1.2011 Emtricitabine (200mg) capsule 09-06-2005 Emtricitabine 200mg 17.02.16 Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir Disoproxil 245mg Tablet (additional Indication) Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength) 17-10-2005 Enalapril 10mg/20mg + HCTZ 12.5mg/25mg tablet 08.10.1992 Enalapril (2.5mg/5mg) + HCTZ (12.5) Tablet (Addl. Strength) 17-10-2005 Enalapril Maleate 2.5mg/5mg/10mg/20mg Tablet August-1989 Enalapril Maleate Bulk September-1989 Enoxaparin Sodium Injection 16-3-2000 Enoxaparin Sodium Injection (Addl.Indication) 19.08.2009 Enoxaparin Sodium Injection 300mg/3ml multidose cartridge (Additional Dosage Form) 31.03.2016 Enrofloxacin 100mg/50mg per ml Injection iEnrofloxacin 50mg/100mg per ml Oral Solution 10-1-1994 (For Veterinary) Enrofloxacin 200 mg + Bromhexine HCl IP 15 mg oral solution. (veterinary product) 30.04.15 Entacapone (200mg) tablet 30-12-2004 Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/0.05mg) per ml. 12-05-2005 Entecavir Tablet (0.5mg/1.0mg) & oral solution (0.05mg/ml). 05-12-2005 Enzalutamide 40 mg soft Capsule 18. 12 .2015 Enzalutamide hard Gelatin Capsules 40 mg 12.07.2017 Epalrestat 50mg + Methylcobalamin 500mcg Tablets 16.11.11 Epalrestat 50mg + Methylcobalamin 500mcg 16.11.11 Tablets Eperisone 50 mg + Paracetamol 500 mg Tablets 10.11.2009 Eperisone 50 mg + Paracetamol 500 mg Tablets 10.11.2009 Eperisone Hcl (50mg ) tablet 23-08-06 Eperisone Hydrochloride Sustained Release 24-06-2011 Capsule 75mg/150mg (Modified Dosage Form) Resonate 50mg Tablet January-1961 Ephedrine Sulphide 75mg Sustained Release Capsule. May-1971 Epicillin (6-aminopenicillanic acid) 250mg/500mg Capsule May-1974 Epicillin 250mg & 500mg Injection August-1979 Epicillin 125mg/5ml & 250mg/5ml Oral Suspension August-1979 Epicillin 250mg/500mg Capsule August-1979 Epi-Growth Factor (1 gm) + Silversulphadiazine Cream FDC of 19-10-2004 Epinastine Hcl (0.05%) Opthlamic solution 22-09-06 Epirubicin Injection July-1986

PHARMADOCX CONSULTANT 43 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Eplerenone Tablet (25mg/50mg) 10-06-2005 Eplerenone Tablets 25mg/50mg (Additional Indication) 14.09.2016 Eplerstat tablet 50mg 25.05.07 Eprinomectin 0.5% for beef and dairy cattle (vet.) 14.03.2017 Eprosartan Mesylate 400 mg / 600mg Tablets 11.10.08 Epsilon Caproic Acid 250mg/ml Injection March-1971 Epsilon Amino Caproic Acid November-1967 Eptifibatide 2mg/ml per 10ml vial Injection 25-8-1999 Eptifibatide 0.75mg/ml per 100ml vial Injection Equine Influenza & Equine Rhino Pneumonnitis Vaccine (For Veterinary) March-1989 Erdosteine (150mg/300mg) Capsules 11-03-2005 Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup 08-08-2006 Erdosteine 150mg + Guaiphenesin 50mg + Terbutaline 1.25mg per 5ml syrup 8-8-2006 Erdosteine Powder for oral suspension 35mg/ml 6-2-2006 Ergometrine 500mcg + Oxytocin 5 units per ml injection 28.07.1995 Eribulin mesylate solution for injection 0.88mg / 2ml vial 27.01.12 Eribulin mesylate solution for injection 0.88mg in 2ml vial (Add. Indication) 18.02.15 EribulinMesylate solution for injection 0.5mg/mL (2mL/vial; intravenous route) 27-10-2016 Erlotinib HCl 25/100 mg Tablet (Additional Indication) 03-07-10 Erlotinib HCl Tablet 150 mg (Additional Indication) 04.01.11 Erlotinib Hydrochloride (25mg/100mg/150mg Tablet 13-07-2005 Ertapenem For injection (1gm/vial) 10.04.07 Ertapenem for injection 1gm/vial (additional indication) 15.01.08 Erysimiine April-1965 Erythromycin 300mg/6ml single pack Intramammary Infusion (For Veterinary) 7-2-2000 Erythromycin Propionate eq. to 50mg of Erythromycin + Benzyl alcohol 0.02ml + Lidocaine Mar-74 0.02gm per ml Inj. EryThropoietin 2000 IU/4000 IU + Mannitol 40mg/40MG + NaCl 7mg/7MG + Monobasic Sod. 15-06-1905 Phosphate 2.8mg/2.8mg + Dibasic Sod. Phosphate 8mg/8mg + Human Albumin 5mg/5mg Lyophilised 2 ml Inj. Escitalopram Oxalate. 24.01.2003 Escitalopram (10mg) + Clonazepam (0.5mg) 27-08-2004 Escitalopram (as oxalate) 10mg + Clonazepam 0.5mg Tablet 31.08.2004 Escitalopram 5mg + Clonazepam 0.5mg Tablet 13.12.2007 Escitalopram Oxalate IP 04.04.14 Eq to Escitalopram 10 mg + Clonazepam IP 0.5 mg (additional dosage form) Each mouth dissolving tablet contains: Escitlopram (as oxalate)10mg + Clonazepam- 0.5mg tablet (addl. Strength). 12.12.07 Escitlopram (as oxalate)10mg + Clonazepam-0.5mg tablet (addl. Strength). 12.12.07 Eslicarbazepine Acetate Tablets 07.03.11 200mg/400mg/600mg/800mg Esmolol Hcl 2.5gm/10ml ampoule Injection 29-8-1994 Esmolol Hcl 100mg/10ml vial Injection Esomeprazole (with Sodium bicarbonate as Buffer) 14.05.2008 Esomeprazole 20 mg/40 mg + Domperidone 30 mg SR Capsule FDC of 29-06-2004. Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules 13-11-06 Esomeprazole (with Sodium bicarbonate as buffer) 20mg/40mg tablets 14.05.08 Esomeprazole 40 mg (as delayed release pellets) 13.02.14 + Levosulpiride 75 mg (As extended release tablet) hard gelatine capsule. Esomeprazole 40mg (E.C.) + Itopride 150mg SR Capsules 13-11-06

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Esomeprazole Delayed Release Granules for 13-05-2011 Oral Suspension: Each 1g sachet contains: Esomeprazole Magnesium I.P(as trihydrate) equivalent to Esomeprazole 10 mg as enteric coated granules (Additional Dosage Form) Esomeprazole Mag. 04.12.2001 Esomeprazole magnesium Delayed Release 06-04-2011 Tablets 20mg/40mg (Additional Indication) Esomeprazole Magnesium eq. to Esomeprazole 20mg/40mg (as enteric coated 01.06.2004 pellets)+Domperidone maleate BP Eq. to Domperidone 30mg/30mg SR Capsules Esomeprazole Sodium For injection 04-04-2005 Estemestane 18.10.2001 Estraderm Transdermal TTS having Estraderm 2mg/4mg/8mg Estradiol. 23-2-1994 Estradiol topical emulsion 2.5mg/gm 16.03.07 Estradiol Valerate 1mg/2mg Tablet 2-3-1998 Estramustine Phosphate Capsule July-1986 Estriol Succinate 2mg Tablet March-1980 Estrogen vaginal tablet 25mcg 2-11-2006 Eszopiclone tablet (1mg/2mg/3mg) 07.02.07 Etanercept-Recomb. 07.12.2001 Ethacridine Lactate February-1973 Ethacridine Lactate- 100mg/200mg Dragee June-1983 Ethacridine Lactate 1mg/ml Injection October-1977 Ethacrynic Acid USP 25mg/50mg Tablet February-1973 Ethambutal Dihydrochloride 100/200/400mg Tablets March-1968 Ethamivan June-1965 Ethamsylate 250mg/2ml ampoule Injection September-1991 Ethamsylate 250mg/500mg Tablet May-1988 Ethanol IP……80% v/v 10.07.2017 Hydrogen Peroxide IP ……0.125% v/v Glycerol IP ……1.45% v/v Solution Each 100ml contains: Ethionamide 250mg Tablet February-1962 Ethosuximide Tablet (250mg) December- 1961 & Syrup (250mg/5ml) Ethyl esters of iodized fatty acids of poppy seed oil solution for injection 48%. 22.08.2012 Ethylestrenol 2mg Tablet June-1962 Ethynodial diacetate 1mg + Mestranal 0.05mg tablet Jan-71 Ethynodiol diacetate 1mg + Ethinyloestradiol 0.05mg Feb-70 Etidronate Disodium 200mg Tablet 10-3-1995 Etizolam 0.25 mg tablet (Additional Strength) 03-07-10 Etizolam CR Tablets 1.5 mg/3 mg (modified 19-12-2011 Dosage Form) Etizolam Tablet (0.5mg/1mg). 29-10-2007. Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet (additional strength) 09.09.10 Etodolac 300mg + Paracetamol 500mg film coated tablet 20.10.2009 Etodolac USP 400mg + Tolperisone HCL 150mg tablet 11.10.10 Etodolac 300/300mg +Thiocolchicoside 4/8mg 19-07-10 Etodolac 300/300mg +Thiocolchicoside 4/8mg 19-07-10 Etodolac 300mg S (+) +Thiocolchicoside 05.01.11 8mg Tablet

PHARMADOCX CONSULTANT 45 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Etodolac 400mg + Paracetamol IP 500mg tablet 01.10.10 Etodolac 400mg + Paracetamol IP 500mg tablet (additional strength) 01.10.10 Etodolac 400mg/400mg + Thiocolchicoside 4mg/8mg tablet 09.09.10 Etodolac BP 200mg/400mg Tablet and Etodolac 300mg Capsule 10-4-1997 Etodolac ER tablets 400mg/500mg 09.05.07 Etodolac i.m injection 400mg/2ml 14-12-15 (Additional dosage form) Etodolac S (+) 150/200/300mg + Paracetamol 500/500/500mg Tablets 25.11.2009 Etodolac S (+) 150/200/300mg + Paracetamol 500/500/500mg Tablets 25.11.2009 Etodolac S (+) 300mg +Thiocolchicoside 8mg Tablet 05.01.11 Etodolac S(+) 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl salicylate 5%w/w + 08-05-2010 Linseed oil 3%w/w gel Etodolac S(+) ER tablets 200mg/300mg 02.06.08 Etodolac S(+) 5/10%w/w + Camphor 4%w/w + Menthol 10%w/w + Methyl salicylate 5%w/w + 05-08-10 Linseed oil 3%w/w Etodolac USP 400mg +Tolperisone HCL 150mg tablet 11.10.10 Etofylline-300mg, Salbutamol (as sulphate)- 4mg SR Capsules 14.06.1993 Etomidate 2mg/ml Injection August-1985 Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings 15-02-2005 Etonogestrel (11.7mg) + Ethinylestradiol (2.7mg) Contraceptive rings 15-02-2005 Etonogestrel 68 mg implant 15.02.2017 Etoposide 100mg/5ml Injection March-1988 Etoposide 50mg Capsule March-1988 Etoposide Capsule & Injection January-1988 Etoricoxib 05-03-2004 Etoricoxib + PCM (60mg + 500mg) Tablets 30.09.08 Etoricoxib + PCM (60mg + 500mg) Tablets 30.09.08 Etoricoxib 1%+ Menthol 5% Spray 16-03-2010 Etoricoxib 1%+ Menthol 5% Spray 16-03-2010 Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of Gel 14-12-06 Etoricoxib 10mg + Methyl Salicylate 100mg + Mentol 50mg + Linseedoril 30mg per gm. of Gel 14-12-06 Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream 21.03.07 Etoricoxib 10mg + Methyl salicylate 20mg per gm. of cream 21.03.07 Etoricoxib injection 90mg/ml 28.03.08 Etoricoxib roll on Topical Solution 1% v/v 16.09.08 Etravirine Tablet 100mg 26.04.12 Euphorbia Prostrata Dry Extract (ethanolic 80% (v/v) (35-70) :100mg tablet 29.02.08 Euphorbia Prostrata dry extract ethanolic 80%v/v[(35-70):1] cream 1% w/w 14.11.2009 Euphorbia Prostrata Dry Extract 14.11.2009 :100mg tablet (addl. Indication) Everolimus 2.5mg/5mg/10mg Tablets 21.3.13 Everolimus 5/10mg Tablets (Addl. Indication) 16.05.2009 Everolimus dispersible Tablet 0.1mg/0.25mg (additional Indication) 21-08-15

Everolimus Tablet 0.25 mg/0.5 mg/0.75 mg/1.0 mg 21-08-15 (additional Indication) Everolimus Tablet 5 mg/10 mg (additional 21-12-2011 Indication) Everolimus Tablet 5 mg/10 mg (additional 27.12.11 Indication) Everolimus Tablets (0.25 mg/ 0.5 mg/0.75 mg/1.0 mg) 30-08-2004

PHARMADOCX CONSULTANT 46 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Everolimus tablets 2.5mg. 5mg and 10mg 08.06.2016 Exemestane 25mg Tablet (Addl. Indication) 29.08.2009 Exenatide 2 mg powder and solvent for prolonged release suspension for injection in a prefilled pen 09-09-15 (s.c. Injection) (Additional strength) Exenatide Inj. (Additional Indication) 24-05-2010 Exenatide Injection (Additional indication) 09.10.10 Exenatide injection (Each 2ml vial contains- Exenatide 5mcg/10mcg per 0.2ml ) (Additional 30.01.08 Strength) Exenatide Injection -pre-filled pen (250mcg/ml). 06-07-2007. Extract of Centella Asiatica 200mg Tablet May-1976 Extract of Centella Asiatica February-1975 Extract of Centella Asiatica 1% Ointment May-1976 Extract of Centella Asiatica 2% Powder May-1976 Extract of Centella Asiatica 2% May-1976 / Vial Extract of Mycobacterium Vaccal eq. to 100mg/ml proteins Injection (For Veterinary) August-1990 Ezetimibe 18-12-2003 Ezetimibe 10 mg + Simvastatin 40 mg (additional strength) Each Uncoated tablet contains: 23.09.14 Ezetimibe 10mg/10mg + Simvastatin 10mg/20mg FC Tablet 05.11.2005 Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets 01.09.2009 Ezetimibe 10 mg + Fenofibrate 145 mg Film coated tablets 01.09.2009 Ezetimibe 10mg + Fenofibrate 160mg tablet 04.04.07 Ezetimibe 10mg + Fenofibrate 160mg tablet 04.04.07 Famciclovir 11.04.2002 Famotidine 10mg/ml Injection April-1990 Famotidine 20mg/40mg/ 10mg Tablet May-1989 Famotidine 40mg/5ml Oral Suspension May-1989 Faropenam Sodium Extended Release Tablet 225/300/450 mg 08-03-2010 FDC of Sucralfate 0.07 + metronidazole 0.01 gm + Lignocain 0.04 gm per gram of cream 19-08-2004 Febuxostat 40mg Additional Strength 16-01-2010 Febuxostat Tablets 80mg / 120mg 14.11.2009 Felodipine 5mg/10mg ER Film Coated Tablet May-1991 Fenbandazole 175mg+Oxycloganide 525mg bolus 04.10.1999 Fenbandazole(vet) 2.5%(w/w)/1.5%(w/w) 04.10.1999 +Oxyclonazide (vet) 7.5%w/w/4.5%(w/w) per ml Fenbendazole January-1979 Fenbendazole (Bulk) January-1983 Hcl 60mg S.R Capsule 9-7-1993 Fenfluramine Hcl January-1972 Fenfluramine Hcl 20mg Tablet April-1972 Fenfluramine Hcl 20mg Tablet December-1972 FenfluramineHydrochloride 60mg Sustained Release Tablet September-1984 Fenofibrate 200mg (micronized) Capsule 22-12-1999 Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets 18.07.08 Fenofovir Disoproxil fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg tablets 18.07.08 Fenoverine 08-10-2003 Fenpipramide Methobromide and P-Piperidinoethoxy o- carbomethoxy benzophenone October-1980 Hydrochloride (Bulk) Fentanyl Transdermal 10,20,30,40cm2 patch containing 2.5/5.0/7.5/10mg of Fentanyl delivers 11-1-1999 25/50/75/100mcg of Fentanyl per hour respectively.

PHARMADOCX CONSULTANT 47 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Fenticonazole Nitrate Vaginal Capsule 600 mg 10.08.2016 Feracrylum (1%) + Metronidazole 1%) 16-09-2005 Feracrylum (1%) + Metronidazole 1%) Gel 16-09-2005 Feracrylum 1% mouth gargle 10mg/ml 28-09-06 Feracrylum 1% w/v Solution 21-5-1992 Feracrylum 3% gel 13-02-2002 Feracrylum 3% solution 13-02-2002 Feropenem Sodium (150mg/200mg) Tablet 21-07-2005 Ferric Carboxymaltose equivalent to 11.02.11 elemental Iron…50mg/ml Injection Ferric Sodium Citrate April-1972 Ferrous Sulphate 150mg Sustained Release January-1971 Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. 8-6-2006 Ferrous ascorbate (equivalent to 50mg Iron) + Folic acid 1.5mg. Film coated tablet 06-08-2006 Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg) 18.08.08 Ferrous Ascorbate + Folic Acid + Zinc FC Tablets (100mg + 1.5 mg + 22.5 mg) 18.08.08 Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) 27.08.08 (New Dosage Form) Ferrous Ascorbate + Folic Acid Suspension (Equiv. to elemental iron 30mg + 550mcg per 5ml) 27.08.08 (New Dosage Form) Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3- fatty acid 200mg capsules 08-01-2010 combikit Ferrous ascorbate 100mg + Folic acid 1.1 mg tablet and Omega-3-fatty acid 200mg capsules 01-08-2010 combikit Ferrous Ascorbate 100mg + Folic Acid IP 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate 05.01.11 Monohydrate Eq. to Elemental Zinc 22.5mg Tablet Ferrous Ascorbate 100mg + Folic Acid IP 05.01.11 1.5mg + Cyanocobalamin IP 15mcg + Zinc Sulphate Monohydrate Eq. to Elemental Zinc 22.5mg Tablet Ferrous ascorbate eq to Elemental Iron 100 mg/50 mg Folic acid IP 1.5 mg Each film coated tablet 31.01.08 contains: Ferrous Ascorbate eq. to elemental iron 100mg 19.10.11 + Folic acid IP 1.5 mg + Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional strength) Ferrous Ascorbate eq. to elemental iron 19.10.11 100mg + Folic acid IP 1.1mg + Methylcobalamin 1.5mg +Zinc Sulphate monohydrate IP eq to elemental Zinc 22.5mg Tablets. (Additional strength) Ferrous bisglycinate 60mg + Folic acid 1mg + Zinc Bis glycinate 15mg + Methylcobalamine 14.10.2008 500mcg FC Tablet Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper 13.10.10 sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule. Ferrous bisglycinate 60mg + Zinc sulphate monohydrate Eq. to Zinc 14mg + Copper as copper 13.10.10 sulphate 1 mg + Selenium as selenomethionine 70mcg + Vitamin B6 IP 10mg + Methylcobalamin 1500mcg + Folic acid 5mg + Fish oil 10/40 (DHA 200mg) 500mg capsule. Ferrous Ethylene Diamine Tetra Acetate Trihydrate, 25mg & 50mg Drops March-1962 Ferrous glycine Sulphate CR 100mg (eq. to elemental iron)+Folic acid 0.5mg tablet 03.11.1992 Ferrous Sulphate 160mg Slow Release Tablet November-1972 Ferrous Sulphate eq. to Elemental Iron 100mg/20mg + Folic Acid IP 0.5mg/0.1mg Enteric coated 15.07.13 tablets (Additional Dosage Form) Fexofenadine Hcl 120mg/180mg Tablet 16-9-1998

PHARMADOCX CONSULTANT 48 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Fexofenadine 60mg + Pseudoephedrine120mg CR Capsule 17.12.2003 Fexofenadine 120mg + Montelukast 10mg Chewable tablet 31-08-10 Fexofenadine 120mg + Montelukast 10mg Chewable tablet (additional Dosage form) 07.07.11 Fexofenadine 120mg + Montelukast 10mg 31-08-10 Fexofenadine 120mg + Montelukast 10mg 07.07.11 Chewable tablet Fexofenadine 120mg+Psendoephedrine sulphate USP in ER form 180mg tablet 17.09.1999 Fexofenadine Hcl 60mg/30mg Tablet 1-11-2000 Fexofenadine suspension (30mg/5ml) 19.01.07 Fibrinolysin (human) 50000 & 100000 units April-1961 Fibrinolysin + Desoxyribonuclease Feb-62 Filgrastim 48MU (1.6ml) & Filgrastim 30MU (1ml) Injection 30-9-1993 Finasteride 5mg Film Coated Tablet 9-10-1996 Fish Gut Sutures 28-8-1996 Flavonoids extracted from Rutacea (Aurantiaceae) containing a standard amount of Diosmin June-1978 Flavophospholipol (Flavomycin) (For Veterinary) September-1989 Flavoxate Hydrochloride 100mg Tablet November-1980 Flecainide Acetate 100mg Tablet 26-3-1993 Flecainide Acetate 150mg/ml (15ml) Injection Fluconazole (2%) + Zinc Pyrethione (1%) suspension 22-02-2005 Fluconazole (2%) + Zinc Pyrethione (1%) suspension 22-02-2005 Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion 15.09.08 Fluconazole + Zinc Pyrethrone (Each 30/60ml bottle contains: 2% + 1%) Lotion 15.09.08 Fluconazole 0.3% w/v per ml Eye Drops 4-2-1998 Fluconazole 50mg/100mg/150mg/200mg Capsule/Tablet 26-4-1993 Fluconazole 2mg/ml i.v Injection Fluconazole 50mg/100mg/200mg Capsule Fluconazole 2mg/ml 100ml/200ml i.v Injection 28-1-1993 Fluconazole 50mg/5ml Oral Suspension 29-5-2000 Fluconazole Dispersible tablets 50mg 22.04.08 Fluconazole For Oral suspension 50/200 mg per 5ml (Pack Size : 35ml) 20-08-10 Fluconazole Gel (0.5%) 12-08-2004 Fluconazole tablet 300mg (Additional strength) 28-11-2011 Fludarabine Phosphate 50mg (eq. to 39.05mg of fludarbine) per vial i.v Injection 22-6-1999 Flumequine (For Veterinary) September-1987 Flumethasone Pivalate 0.02% + lodochlorohydroxyquinoline 1% ear drops Oct-72 Flumethrin 1gm/100ml Solution 1% (For Veterinary) 29-10-1997 Flunarizine Hcl 5mg/10mg Capsule and Flunarizine Hcl 10mg Tablet November-1990 0.025% w/v Nasal Spray 30-11-1993 Fluocinolone Acetonide August-1962 Fluocortolene + Flucortolene Caproate Jul-68 Fluocortolone 2.5mg + Fluocartalone caproate 2.5mg + Neomycin Sulphate 5mg per gm ointment Nov-78 Fluocortolone caproate 0.25gm + Flucortolone Trimethylacetate 0.25gm per 100gm cream Jun-78 Fluocortolone trimethylacetae 0.612mg + Flucartolone caproate 0.630mg + Clemizole undecyclate Oct-78 5mg + Cinclocamic HCl 1mg Suppositories Fluocortolone trimethylacetae 0.92mg + Flucartolone caproate 0.95mg + Clemizole undecyclate Oct-78 10mg + Cinclocamic HCl per gm ointment Fluorescein Sodium Solution for Injection (100mg/ml) 2-3-2006 Fluorometholone USP 1mg+Gentamicin 3mg (as sulphate) per ml eye drops 28.07.2000 Fluorometholone 0.1% Ophthalmic Suspension Fluorometholone Forte 0.25% Liquifilm Suspension 26-7-1996

PHARMADOCX CONSULTANT 49 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Fluorometholone 1mg+ Neomycin sulphate 3.5mg (as base)+Benzalkonium chloride 0.04mg per ml 04.09.1996 Ophthalmic suspension Fluorouracil December-1964 Fluorouracil (5-) 250mg/5ml Oral Solution January-1979 Fluorourail (5-) 250mg Capsule November-1977 Fluoxetine Hcl 20mg/60mg Capsule & Fluoxetine Hcl 20mg/5ml Syrup March-1990 Flupenthixol January-1977 Flupenthixol Decanoate 20mg/ml Injection July-1977 Flupenthixol dihydrochloride eq. to flupenthixol 0.5mg + Melitracen Hcl eq. to Melitracen 10mg 28.10.1998 sugar coated Tablet Flupenthixol Hydrochloride 0.5mg Tablet February-1977 Flupenthixol Tablet (FlupenthixolHydrochloride equivalent to Flupenthixol0.5mg/ 1mg) 23.07.1981* Fluphenazene 0.5mg Tablet May-1961 Enanthate 25mg (1c.c) December-1967 Fluphenazine Decanoate September-1972 Fluphenazine Decanoate 2mg/ml Injection September-1973 Flupirtine Maleate Capsules 100mg 12-06-2010 Flupirtine Maleate Sustained Release Tablets 400mg 18.10.12 Fluprednidene acetate 0.1% + Gentamicin as Sulphate 0.1% Cream Feb-80 Fluprednylidene acetate 0.1% + Gentamicin Sulphate 0.1% + 5-Chloro-8-hydroxygluconate 0.5% Oct-78 Cream Fluprednylidene-21-Acetate December-1977 Fluprednylidene-21-Acetate 0.1mg/100gm Cream January-1978 Fluralaner chewable tablets 112.5 mg/250 mg/500mg/1000mg/1400 mg 30.5.2017 Flurazepam (as Hcl) 15mg/30mg Capsule August-1985 Flurbiprofen 0.03% Eye Drops July-1989 Flurbiprofen 200mg SR Capsule June-1990 Flurbiprofen 50mg/100mg Tablet July-1979 Flurbiprofen plaster 20 mg (7cm X 10cm) 11.12.2009 Flurbiprofen Sodium 0.03% Ophthalmic solution USP 14.11.2009 Flurometholone 10mg + Gentamicin 3mg (as sulphate) per ml Eye Drops 28.04.1997 Flutamide 250mg Tablet June-1986 Fluticasone Furoate (100 mg mcg) and Trifenatate (25 mcg) powder for inhalation 29.06.2017 Fluticasone furoate Nasal spray 27.5mcg per spray 19.03.09 B.P 0.5mg/2.0mg per 2ml Respule 27-11-2000 Fluticasone Propionate 0.05% 18-3-1996 Cream Fluticasone Propionate 0.005% Ointment Fluticasone Propionate 0.05% Nasal Spray Fluticasone Propionate 500mcg/250mcg/100mcg + (as the xinofoate) 50mcg Accuhaler 29.03.2000 Fluticasone Propionate 500mcg/250mcg/100mcg + Salmoterol (as the xinafoate) 29.03.2000 50mcg/50mcg/50mcg inhalation powder Fluticasone Propionate 50mcg/125mcg/250mcg + Salmeterol xinafoate 25mcg/25mcg/25mcg 25-05-2010 Powder for inhalation Fluticasone Propionate 50mcg/125mcg/250mcg 25-05-2010 + Salmeterol xinafoate 25mcg/25mcg/25mcg Powder for inhalation Fluvastatin Sodium 25-11-2003 FluvAstatin Tablet (As calcium) 10mg/20mg/40mg (additional strength) 29.01.07 Fluvestrant 250mg/5ml Injection(Additional 20-04-2011 Dosage Regime) Fluvoxamine Maleate 50mg/100mg Film Coated Tablet 21-2-2000 Fluvoxamine Maleate100/150mg ER Tablets 19.08.2009

PHARMADOCX CONSULTANT 50 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Folic Acid 0.5mg + Ferrous Sulphate 150mg Capsule Jan-69 Fondaparinax Sodium 22-10-2003 Fondaparinax Sodium injection (Additional Indication) 28.01.08 Formestane Sterile 250mg (i.m) Depot Injection 6-3-1995 Formoteral Fumarate 6mcg/6mcg + Budesonide B.P. 100/200mg Capsule Inhaler 17.08.2001 Formoterol 4.5mcg/4.5mcg + Budesonide 80/160 mcg Inhaler 16.10.2003 Formoterol fumarate 4mcg/6mcg+Budesonide- 80mcg/160mcg 16.10.2003 Formoterol fumarate 6mcg+Budesonide- 400mcg capsule 07.03.2002 Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg MDI 14-10-06 Formoterol Fumerate 12mcg Capsule (Rotacap) Formoterol Fumerate 12mcg Inhaler 18-2-2000 Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder 30.12.2009 Inhalation Formoterol 6 mcg + Mometasone furoate 100/200/400mcg Metered dose Inhaler & Dry Powder 30.12.2009 Inhalation Formoterol Fumarate (6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder inhaler 10-5-2006 Formoterol Fumarate (6mcg/6mcg/6mcg) + Fluticasone Propionate (100/250/500mcg) dry powder 05-10-2006 inhaler & MDI Formoterol fumarate 6mcg + Fluficasone propinate 50mcg/125mcg/250mcg MDI 14-10-06 Formotnol fumarate 6mcg+ Budesonide BP 400mcg per actuation inhaler MDI/DPI 23.04.2002 Formotorol fumarate-6mcg/6mcg+Budesonide 100mcg/200mcg per actuation 19.11.2001 Forskolin Eye drop (1%). 27-07-2006 Fortison Liquid/Powder, Pepti-2000 Liquid/Powder 27-1-1995 Fosaprepitant (as Dimeglumine) for Injection 150mg. 16.12.11 Fosfomycin Tromethamine Sachet 3gms 09.10.08 Fosinopril Sodium 10.01.2002 Fosphenytoin Sod. 01.10.2002 Fotemustine Powder 208mg (with solven) per vial i.v Injection 23-12-1996 Framycetin Sulphate 1% + Hydrocortisone Acetate 1% + Miconazole nitrate 2% Apr-87 Framycetin sulphate 1% + Dexamethasone 0.1%+Clotrimazole 1% Cream 28.10.1993 Fresemide 20mg+Potassium chloride 750mg each tablet Mar-89 Frontline Plus (Cats) contains: 13.04.2016 Fipronil 9.8% (S)-Methoprene 11.8% Frontline Plus (Dogs) contains: Fipronil 9.8% (S)-Methoprene 8.8% Spot-on-solution (veterinary formulation) Frusemide 20mg +Potassium Chloride IP 750mg tablet 07.03.1989 Frusemide 20mg/20mg + Spironolactone 50mg/100mg each capsule/tablet Sep-84 Frusemide 40mg/20mg+Potassium Chloride 600mg/300mg tablet 26.02.1993 Fulvestrant Inj. 250mg/5ml prefilled syringe 30-08-06 Furaltadone June-1973 Furaltadone 20% w/w Powder (For Veterinary) August-1973 Furosemide Tablet & Ampoule April-1965 Fusafungine January-1977 Fusafungine 26-3-1996 Fusafungine Hcl 25mg Aerosol March-1977 Fusidic Acid BP 10mg/gm Eye Drops 3-3-1992 Fusidic Acid Hemihydrate Eye Drops March-1992 Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet FDC of 08-05-2005 Gabapentin 300mg/400mg Capsule 3-8-1995 Gabapentin (300mg) + Methylcobalamin (500mcg) Tablet FDC of 05-08-2005 Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength) 24.01.08

PHARMADOCX CONSULTANT 51 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Gabapentin 100mg + methylcobalamin 500mcg tablets (Additional Strength) 24.01.08 Gabapentin ER 450/600/900mg tablet 15-12-06 Gabapentin SR 600mg tablets 30.01.08 Gadobenate dimeglumine IV Injection 11-08-2011 (Gadobenate dimuglimine 529mg equivalent to Gadobenate acid 334mg + Meglumine 195 mg) (Additional Indication) Gadobenate(Dimeglumine IV Injection) 07.03.2003 Gadobutrol solution for injection 07.05.2015 Gadodiamide 287mg/ml Injection eq. to 0.5 m mol (in 10ml vial) 21-1-1994 Gadopentetic Acid Dimeglumine Salt 469.01mg/ml Injection 6-5-1992 Gadopentetic acid dimeglumine salt injection 469mg/1ml (0.5mmol) (Additional indication) 23.02.15 Gadoteric acid 27.932gm+ Meglunine 9.76gm each 100ml for I.V. Inj. 23.10.2002 Gadoversetamide Injection 04.06.2003 Galanthamine Hydrobromide Tablet & Injection December-1978 Gamma benzene Hexachloride IP 0.10% w/v Proflavin Hemisulphate 0.10% w/v Cetrimide IP 0.45 15.07.15 % w/v (veterinary product) (Additional dosage form) Spray dosing form contains: Ganciclovir 250mg Capsule Ganciclovir 500mg per vial Injection 5-4-2000 Garenoxacin Mesylate tablets 200mg 07.06.13 Gatifloxacin 03.10.2001 Gatifloxacin (as sequihydrate)-3mg + Flurbiprofen sod.-0.3mg/ml eye drops. 29.11.07 Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops 06-02-2006 Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop 24.07.08 Gatifloxacin 3mg+ Dexamethasone 1mg Eye Drop 18.06.2004 Gatifloxacin (0.3%) + Prednisolone Acetate (1%) eye drops 2-6-2006 Gatifloxacin (200mg) + Ornidazole (500mg) tablet 06-06-2005 Gatifloxacin (200mg) +Ornidazole (500mg) tablet 06-06-2005 Gatifloxacin (400mg) + Ambroxol HCl (75mg) tablet FDC of 21-12-2004 Gatifloxacin (as sequihydrate)-3mg 29.11.07 + Flurbiprofen sod.-0.3mg/ml eye drops. Gatifloxacin 0.3% + Dexamethasone Phos. 0.1% w/w Eye drops FDC of 15-06-2004 Gatifloxacin 0.3% + Ketorolac Tramthamine 0.4% eye Drop 24.07.08 Gatifloxacin 0.3% + Loteprednol Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic 19.05.11 suspension Gatifloxacin 0.3% + Loteprednol 19.05.11 Etabonate 0.5% + Benzalkonium Chloride 0.01% w/v Opthalmic suspension Gatifloxacin Eye drop 5 mg/ml 21.02.11 Gatifloxacin Eye Ointment (1%) 06-10-2004 Gatifloxacin IP eq. to Gatifloxacin (Anhydrous) 3.0mg + Difluprednate 0.5mg + Benzalkonium 24.10.11 Chloride IP (As preservative) 0.01% w/v Eye Drops Gatifloxacin IP eq. to Gatifloxacin 24.10.11 (Anhydrous) 3.0mg + Difluprednate 0.5mg + Benzalkonium Chloride IP (As preservative) 0.01% w/v Eye Drops Gatifloxacin sesquihydroate eq. Gatifloxacin 400mg + Ambroxol HCl SR 75mg film coated 24.12.2004 bilayered Tablet Gefitinib 17-02-2004 Gefitinib tab 250mg (Additional Indication) 18.12.2009 Gel contains: 30.01.08 Diclofenac Diethylamine BP eq to Diclofenac sodium 1 % w/w Methyl salicylate IP 10 % w/w Menthol IP 5 % w/w Linsed oil BP 3.0 w/w Gemcitabine Hcl 200mg/1000mg Injection 24-1-1996 Gemcitabine (1.4 gm/vial) 01-09-2004 Gemcitabine HCl injection 2gm/vial (Additional Strength) 03-07-10

PHARMADOCX CONSULTANT 52 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Gemcitabine HCl injection ready to use infusion bags 17.06.2014 Gemcitabine HCL equivalent to Gemcitabine 10mg per mL (100,120,130,140,150,160,170,180,190 and 200mL) (Approved as infusion bags) Gemcitabine Hydrochloride for injection 2g/vial 27-10-2011 (New dosage form) Gemcitabine in combine with cisplatin Gemcitabine Injection 38mg/ml 5.12.12 Gemcitabine Injection 38mg/ml 6.12.12 Gemfibrozil 300mg/900mg Capsule August-1988 Gemfibrozil Capsule USP & Gemfibrozil Tablet USP 200mg/600mg (Addl. Indication) 05-04-2010 Gemifloxacin (as msylate) 320mg tablet 30-08-06 Gemifloxacin + Ambroxol (320mg + 75mg SR) FC Tablets 24.12.08 Gemifloxacin + Ambroxol (320mg + 75mg SR) FC 24.12.08 Tablets Gemigliptin 50mg tablets 21.08.15 Gemtuzumab 12.09.2002 Genirelix 08.10.2001 Genotropin 4iu/12iu/16iu Injection 5-9-1994 Gentamicin Sulphate July-1968 Gentamicin sulphate (eq to Gentamicin base) 2mg/ml Injection January-1978 Gestodene 75mcg + Ethinylestradiol 30mcg tablet Jul-88 Gestodene 75 mcg+ Ethinylestradiol BP 20 mcg sugar coated tablet(additional strength) 03.02.14 Ginkgo biloba extract Tablet 120mg (Additional strength) 9-12-2014 Ginko Biloba 40mg Film Coated Tablet 8-9-1992 Glatiramer Acetate Injection (20mg/ ml) & Pre-filled syringe (20mg/ml) 3.06.2009 Glatiramer Acetate injection (20mg/ml) 21.02.07 Glibenclamide 2.5mg/5mg+Metformin 500mg/500mg SR tablet 20.08.2004 Glibenclamide 2.5mg+Metformin 400mg Film coated Tablets 30.11.1995 Glibenclamide IP 2.5mg + Metformin IP 400mg film coated tablets 06.02.1996 Glibenclamide 2.5 mg/ 5 mg + Metformin SR 500 mg tablet FDC of 20-08-2004 Glibenclamide 2.5/5mg Metformin HCl IP 500mg (SR) Each tablet contains: 04.08.2004 Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tablets 23.02.09 Glibenclamide 5mg + Pioglitazone 15mg + Metformin500mg film coated tablets 23.02.09 Glibenclamide 5mg+ Metfermin 500mg Tablets 26.11.1996 Glibeneclamide 5mg + MetFormin SR 850mg tablet (additional strength) 15.02.07 Glibeneclamide 5mg + Metformin SR 850mg tablet (additional strength) 15.02.07 Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg Tablet 19-07-10 Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tablet 22-08-06 Gliclazide 30mg Modified Release Tablet 4-11-2000 Gliclazide 40/80mg+Metformin 500mg+Pioglitazone15mg 19-07-10 Gliclazide 40mg/80mg + MetFormin Hcl 500mg + Rosiglitazone 2mg tablet 22-08-06 Gliclazide 80mg Tablet November-1988 Gliclazide M.R. (30mg/60mg)+ 27-04-2005 Metformin HCl (500mg) ER Tablet Gliclazide M.R. (30mg/60mg/ 80mg)+Metformin HCl (500mg/500mg/500mg) ER Tablet 27-04-2005 Glimeperide 1mg+Rosiglitazone 4mg 12.12.2003 Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets 17.12.2009 Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) Tablet FDC of 12-08-2005 Glimepiride (1mg/2mg) + Pioglitazone (15mg)+ Metformin (500mg E.R) uncoated Tablet FDC of 16.08.2005 Glimepiride 1/2 mg + Metformin 500 mg + Atorvastatin 10 mg tablets 17.12.2009 Glimepiride 1mg/2mg + Metformin 500mg SR Tablet 13.11.2002 Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength) tablet 08.06.07 Glimepiride 1mg/2mg. + Metformin SR 1000mg tablet (additional strength) 08.06.07 Glimepiride 1mg/2mg/3mg/4mg Tablet 24-1-1999 Glimepiride IP 0.5 mg+ Metformin Hydrochloride ER 500 mg uncoated bilayered tablets 20.01.14 (additional strength)

PHARMADOCX CONSULTANT 53 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Glimepiride1mg/2mg + Metformin Hcl I.P.500mg/500mg in SR form tablet 13.11.2002 Glipizide 5mg/10mg GITs Tablet 21-8-1996 Glipizide 2.5mg/5mg +Metformin 250mg/500mg tablet 20-03-1998 Glucagon Injection October-1978 Glucomannan 0.75gm/1.0gm/1.3gm Sachet 6-9-1993 Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets 03.11.2009 Glucosamine sulphate potassium chloride 500 mg + Ibuprofen IP 200mg film coated Tablets 03.11.2009 Glucose 13% + SMOFlipid 20% (Soya bean Oil + Triglycerides medium 26.07.2017 chain + Olive Oil, Refined + Fish Oil, Rich in omega-3-acid) + Amino acid solution (Emulsion for Infusion) FDC of Glucose 13% + SMOFlipid 20% 26.07.2017 (Soya bean Oil + Triglycerides medium chain + Olive Oil, Refined + Fish Oil, Rich in omega-3-acid) + Amino acid solution (Emulsion for Infusion) FDC of Glucose 42% + Amino acid solution with electrolyte + Lipid Emulsion 26.07.2017 for Infusion FDC of Glucose 42% + Amino acid 26.07.2017 solution with electrolyte + Lipid Emulsion for Infusion FDC of Glutaraldehyde 15% +cocobenzyl dimethyl ammonium chloride10% + dye <0.1% + perfume 6% + 24.08.1999 soften water-0.5% per litre Glutathione for Injection 600mg 14.09.11 Glybenclamide April-1970 Glybenclamide 5mg Tablet August-1970 Glybenclamide 5mg Tablet September-1971 Glycapyrrolate 500mcg + Neostigmine 2500 mcg per 5 ml injection 04.11.2002 Glycopyrrolate 0.2mg/ml Injection December-1979 Glycopyrrolate-500mcg+ Neostigmine Methyl sulfate-2500mcg per 5 ml injection 11.04.2002 inhalation powder hard capsule with inhaler. Each capsule contains 63mcg 01.04.2014 Glycopyrronium bromide eq. to Glycopyrronium 50 mcg. Glydiazinamide February-1976 Goserelin acetate 3.6mg Injection 24-4-1996 Gramicidin April-1965 Granisetron Hcl 1mg/2mg Film Coated Tablet Granisetron Hcl 1mg/ml Injection 5-7-2000 Guaiphenasin Syrup 133mg/5ml 18.12.2009 Guaiphenesin ER Tablet (600mg) 28.08.08 Guaiphenesin ER Tablet 1200mg 16.05.2009 Guanethidine (as sulphate) 10/25mg Tablet April-1961 Guanethidine Sulphate (10mg/ml) Ampoule October-1969 Gugulipid June-1986 Gugulipid eq. to Guggulsterone 25mg Tablet March-1987 Haemmacel 500ml bottles May-1965 Haemocoagulase isolated from Bothrops 04.08.2004 Atrox or Bothrops Jararaca 0.2 CU Chlorhexidine Gluconate solution 0.1% w/w Each gm of gel contains: Haemocoagulase isolated from Bothrops 04.08.2004 Atrox or Bothrops Jararaca 0.2 CU Chlorhexidine Gluconate solution 0.1% w/w Each gm of gel contains: Haemocoagulase isolated from Bothrops 22.11.2004 Atrox or Bothrops Jararaca 1.0 CU Chlorhexidine Gluconate solution 0.1% w/w (additional strength) Each gm of gel contains:

PHARMADOCX CONSULTANT 54 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Haemocoagulase isolated from Bothrops 22.11.2004 Atrox or Bothrops Jararaca 1.0 CU Chlorhexidine Gluconate solution 0.1% w/w (additional strength) Each gm of gel contains: Haemodialysis Powder/Liquid Form containing citrate 31.01.08 Haemophilus Type-b Conjugate Vaccine 13-12-1994 Halcinonide July-1976 Halcinonide 1mg + Neomycin sulphate eq. to 2.5mg of neomycin base ointment/cream Jul-79 Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment. 01-08-2007. Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength) 14.05.08 Halobetasol 0.5mg + Miconazole 20mg per gram Cream 31.01.08 Halobetasol 0.05% + Clotrimazole 1.0% cream 04.01.08 Halobetasol 0.05% + Clotrimazole 1.0% cream 04.01.08 Halobetasol 0.05% + Salicylic acid 6% Ointment (additional Strength) 14.05.08 Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel Each gm contains: 16.05.09 Halobetasol 0.05% w/w + Mupirocin 2.0 % w/w gel Each gm 16.05.09 contains: Halobetasol 0.50mg + Fusidic acid 20mg Cream 23.02.2009 Halobetasol 0.5mg + Miconazole 20mg per gram Cream 31.01.08 Halobetasol Propionate (0.5mg) + Salicylic Acid 30mg per gm of ointment. 01-08-2007. Halobetasol Scalp Approved 0.05% w/v 18.02.09 Halobetazol Propionate Cream (0.05%) 02.02.07 Halofuginone (For Veterinary) July-1980 Halometasone monohydrate 0.05% w/w + Fusidic acid 2.00% w/w cream 15.12.2009 Halometasone (as monohydrate ) 0.05% Cream 13.09.08 Halometasone monohydrate 0.05% w/w + 15.12.2009 Fusidic acid 2.00% w/w cream Haloperidol (Bulk) March-1969 Haloperidol 0.25mg Tablet May-1969 Haloperidol Decanoate 50mg/ml & 100mg/ml Injection February-1990 Haloperidol Tablet (0.5mg) (addl. Lower strength) 30-03-2006 Halquinol September-1965 Hamycin 0.1% per gm Hair Cream September-1992 Hamycin Glycerine (300,000 Units/ml) Suspension January-1971 Hamycin Vaginal Tablet & Suspension November-1961 Heparin Sodium 2 units + Sodium Chloride 9mg per ml 26.03.2002 Heparin Sodium Topical Solution 1000 IU/ml (Additional Dosage Form) 16.1.2014 Heparinoid & Hyaluronidase Ointment December-1967 Hepatitis B surface antigen (HBsAg) 31-10-2000 20mcg/ml,100mcg/100ml, 10mcg/0.5ml per vial Hepatitis-B Vaccine (recombinant) Hepatitis B Vaccine (recombinant DNA) January-1987 Hepatitis A (GBM strain) virus-160 antigen unit per 0.5ml dose 5-2-1998 Hexadimethrine Bromide (1.33mg for 100USP units of Heparin) 10mg/ml & 10ml Vials April-1962 Horse Anti Human Lymphocyte Globulin May-1991 HPMC 0.3% +Dextran 0.1% + Glycerin 0.2% eye drop 07-06-2010 HPMC 0.3% +Dextran 0.1% + 06-07-10 Glycerin 0.2% Human Placental Extract Injection September-1978 Human Follicle Stimulating Hormone (FSH) and Human Leutenising Hormone (LH) Injection October-1978 Human Insulin (r-DNA) Powder inhaler 30-08-06 Human Recombinant Granulocyte Colony Stimulating Factor Inj. 29.06.2001 Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringe 30.01.08 Hyaluronic acid (cross linked) Pre-filled syringe 18mg/0.6ml and 24mg/0.8ml 31.01.09 Hyaluronic Acid Pre- filled Syringe 05-05-2011 30mg/2ml& 60mg/4ml(Additional Strength) Hyaluronic Acid Salt 25mg + Cross-Linked Hyaluronic acid 25mg per ml in prefilledsyringe 30.01.08 Hyaluronic Acid Sodium Salt 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube 31.03.09

PHARMADOCX CONSULTANT 55 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads 31.03.09 impregneted with cream. Hyaluronic Acid Sodium Salt 31.03.09 (i) Each 15gm tube contains: HyaluronicAcid Sodium Salt 0.2gm/100gm (ii) Sterile Gauze Pads impregnated with cream: Each gauze pad containsHyaluronic Acid Sodium Salt 50/100mg Hyaluronic Acid Sodium Salt 31.03.09 0.2 gm + Silver Sulfadiazine 1.0 gm/25 gm tube Hyaluronic Acid Sodium Salt 50 mg + Silver Sulfadiazine 1.0 gm/ 100 gm gauze pads impregneted with cream. Hydralazine tablets BP 25 mg (Additional Strength) 23.02.2017 Hydralazine tablets BP 25mg (Additional Strength) 23.02.2017 Hydralazine tablets BP 50 mg 23.02.2017 (Additional Strength) Hydralazine tablets BP 50mg (Additional Strength) 23.02.2017 Hydrocarticosone acetate 1%w/w+ Nitrofurazone 0.2%w/w cream Jun-73 Hydrocortisone (10% w/w) Enema Foam 9-8-1999 Hydrocortisone 17-butyrate 0.1% Cream/Ointment August-1985 Hydrocortisone Aceponate 0.584mg/ml Cutaneous Spray Solution (Vet.) 06.01.17 Hydroflumethiazide 25mg Tablet March-1971 Hydroflumethiazide 25mg/50mg + Rauwalfia 50mg/50mg Tablets Mar-71 Hydroquinone 2% + Tretinoin 0.025% (w/w) 31.01.08 Momentasone 0.10% Gel Hydroquinone 2%+ Tretinoin 0.05% + Hydrocortisone1%Cream 23.02.09 Hydroquinone 2% + Tretinoin 0.025% (w/w) 31.01.08 Momentasone 0.10% Gel Hydroquinone 20mg + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream 23.02.09 Hydroquinone 20mg 23.02.09 + Tretinoin 0.25mg + Fluocinolone Acetonide 0.1mg per gm Cream Hydroquinone USP 2% w/w + Tretinoin USP 0.025% w/w + Allantoin USP 1%w/w Gel 31.01.11 Hydroquinone USP 2% w/w + Tretinoin 31.01.11 USP 0.025% w/w + Allantoin USP 1%w/w Gel Hydroquinone 23.02.09 2%+ Tretinoin 0.05% + Hydrocortisone1%Cream Hydrotalcite 500mg + Smithicone (activated) 125mg Tablet & Hydrotalcite 500mg + Smithicone Jun-86 (activated) 125mg per 5ml Suspension Hydroxy ethyl starch 10% Solution for infusion 18.7.2009 Hydroxychloroquine 400mg tablets (Additional Strength) 31.01.08 Hydroxychloroquine Sulphate (Additional 17.10.08 indication ) Hydroxychloroquine Sulphate Tablet 300mg (Additional strength/indication) 9-8-2014 Hydroxychloroquine Sulphate USP 400 mg tablets (Additional Indication) 28.07.2014 Hydroxycobalamine Injection July-1961 Hydroxyethyltheophylline 231mg + monohydrate 69mg SR Tablet Jun-81 Hydroxyurea USP 500mg Capsule January-1971 Hydrochloride SR Tablets 25/50/75mg 20-08-10 Hylan GF 20 Injection (Synvisc) (Additional Indication) 31.03.08 Hyoscine Butylbromide 20 mg tablet (Additional Strength) 04.11.10 Hyoscine-N-butyl Bromide 7.5mg/10mg Suppository 23-8-1999 Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet 12-08-2005 Hyoscine-N-Butylbromide (10mg) + Paracetamol 500mg Tablet 08-12-2005 Hyper Immune Rabies Serum (Potency 1.20 I.U/ml) March-1969 Ibandronic Acid Inj ( 1 mg/ml) 18-05-2004 Ibandronic Acid Tablet (150mg) addl. Strength 25-05-2006 HCl 03-10-2003 Ibrutinib Hard gelatin Capsule 140mg 07.10.2015 Ibuprofen 100mg/5ml Suspension April-1979

PHARMADOCX CONSULTANT 56 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Ibuprofen 200 mg Tablet September-1971 Ibuprofen 200mg Tablet March-1971 Ibuprofen 400mg + Chlorzoxazone 500mg Tablets 04-07-2010 Ibuprofen 400mg + Chlorzoxazone 500mg Tablets 07-04-2010 Ibuprofen 400mg+ Paracetamol 325mg tablet Oct-84 Ibuprofen 5% w/w & 10% w/w Cream and Ibuprofen 10% Gel July-1990 Ibuprofen 600mg Controlled Release Tablet & Ibuprofen 200mg/300mg/400mg/ 800mg SR March-1990 Capsule Ibutilide Bulk & Ibutilide Fumarate Injection 0.1mg/ml 10.06.16 Icodextrin 7.5% peritoneal dialysis solution 8-6-2006 Idaravone Injection (1.5mg/ml). 26-07-2007. Idebenone 30mg Sugar Coated Tablet 26-9-1997 Idoxuridine (0.5% ophthalmic sol.) Eye Drops July-1967 Ifosfamide September-1978 Ifosfamide 200mg/500mg/1gm per Vial March-1979 Ilaprazole Tablets 5mg/10mg 05.04.11 Iloperidone Tablets 1mg/2mg/4mg/6mg/8mg /10mg/12mg 17.02.11 Imatinib Mesylate 09.12.2001 IMATINIB mesilate100/400mg tablets and 100 mg capsules (Additional 9-9-2014 indication) Imatinib mesylate 100 mg/400mg Tablets and 11-08-2011 100mg Capsules (Additional Indication) Imatinib mesylate 100 mg/400mg Tablets 15-11-2011 (Additional Indication) Imatinib Mesylate 100/400mg Tablets (Addl. Indication) 05-04-2010 Imidacloprid 10% + Moxidectin 1.0% & 2.5% Topical solution (Veterinary) Each pippette contains: 03.10.09 (a) 0.4ml, 1.0ml, 2.5ml, 4ml of 10% Imidacloprid and 1.0% moxidectin (b) 0.4ml, 0.8ml of 10% Imidacloprid and 2.5% moxidectin Imidapril 23-02-2004 Imipenem (as anhydrous) 250mg /500mg + Cilastatin Sodium eq. Cilastatin 250mg/500mg per vial 25.07.2003 Imipenem +Cilastatin 25-07-2003 Imipenem 50mg + Clistatin 50mg 14-07-10 Imipenem 50mg + Clistatin 50mg Injection 14.07.2010 Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP (sterile) eq to Cilastatin 28.06.12 1 g Powder for Injection (Additional strength) Imipenem IP (Sterile) eq to anhydrous Imipenem 1 g + Cilastatin Sodium IP (sterile) eq to Cilastatin 28.06.12 1 g Powder for Injection (Additional strength) Pamoate 75mg/150mg Capsule January-1979 Imipramine Pamoate 75mg/150mg Capsule May-1979 Imiquimod Cream 5% w/w 28-12-2004 Inactivated Rabies Vaccine (Human diploid cell) April-1981 ( as Maleate ) Inhalation 24-04-2010 Powder Hard Capsules ….. ...150/300mcg Indacaterol Maleate 110 mcg Glycopyrronium Bromide 50 mcg inhalation powder, hard gelatin 22.07.14 capsules Each capsule contains: Indapamide (SR) 1.5mg/1.5mg +Nebivolol 2.5mg/5mg tablet 05-12-2010 Indapamide (SR) 1.5mg/1.5mg 12-05-2010 +Nebivolol 2.5mg/5mg tablet Indapamide 1.5mg SR Coated Tablet 12-6-1996 Indapamide 1.5mg/1.5mg + Ramipril 2.5mg/2.5mg FC Tablet 08.07.2009 Indapamide Hemihydrate 2.5mg Tablet November-1978 Indapamine USP(as sustained release form) 1.5 mg + Amlodipine Besilate IP Eq to Amlodipine 09.05.14 2.5 mg (additional strength) Each film coated tablets contains: Indinavir Sulphate 01.02.2001 Indomethacin August-1965

PHARMADOCX CONSULTANT 57 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Indomethacin 50mg/100mg Suppositories July-1970 Indomethacin Injection 1mg/vial 30.04.15 (additional Dosage form) Infectious Bursal Disease Vaccine Inactivated (For Veterinary) March-1986 Infectious Coryza Vaccine (Inactivated) (For Veterinary) March-1987 Infliximab 100mg/10ml vial i.v Injection 25-1-2000 Influenza Vaccine Inactivated (Vaxigrip) 13-8-1996 Influenza Vaccine Inactivated for Equine (For Veterinary) November-1987 Injection of Iron Sorbitol Citric Acid Complex November-1967 Insulin Lispro Mixtures (rDNA) Injection 31-7-2000 Interferon Alpha 2b Injection. May-1988 Intralipid 30% 12-05-2005 Intralipids Intravenous Fat Emulsion October-1981 Intravenous Fat Emulsion with Medium chain triglyceride Solution (10%) : Soyabean Oil USP 11.07.2001 5gm+ Medium chain triglycries BP 5gm+ Egg lecithin 1.20g+Glyccerol IP 2.50gm+ water for injection q.s. per 100ml solution Intravenous Fat Emulsion with Medium chain triglyceride Solution (20%) : Soyabean Oil USP 11.07.2001 10gm+ Medium chain triglycries BP 10gm+Egg lecithin 1.20gm+Glyccerol IP 2.50gm+ water for injection q.s. per 100ml solution Iobenzamic acid August-1965 Iobitridol 17.10.2001 Iobitridol Solution for Injection Each 100mg solution contain 65.81 g Iobitridolcorressponding mass 19.3.13 of Iodine 30gm Iodamide 300/350 October-1967 Iohexol Sterile Solution June-1986 Iomeprol corresponding to 300mg/400mg Iodine per ml Injection 5-10-2000 Iopamidol Sterile Solution June-1986 Iopromide 0.499g/0.623g/0.769g per ml July-1990 Iopromide injection (Equ. To 300 & 370mg of 05-12-2011 Iodine) (Additional Indication) Ioversol 160/240/300/320/350 Injection 29-12-1993 20mcg Nasal Spray 8-4-1993 Ipratropium Bromide 20 mcg Inhaler 20-11-1992 Ipratropium Bromide 250mcg/ml Respirator Solution 8-4-1993 Ipratropium Bromide 500mcg+Salbutamol sulphate eq. to Salbutamol 2.5mg per 2.5 ml respiratory 03.04.2001 solution Irbesartan 150mg/300mg+ Hydrochlothiazide- 12.5mg/ 12.5mg tablet 31.01.2001 Irbesartan 75mg/150mg/300mg Uncoated Tablet 26-6-2000 Irinotecan HCl Trihydrate Injection 20 mg/ml (Pack Size 25ml) 31.08.10 Iron (III) isomaltoside 1000 solution for injection/infusion 100mg per ml 20.08.13 Iron Amino Acid Chelate as Ferrous Bisglycinate (75mg) eq. to Elemental Iron 15mg 22.12.11 + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg +Zinc Picolinate (26mg) eq. to Elemental Zinc 5.5mg Syrup Iron Amino Acid Chelate as Ferrous 22.12.11 137. Bisglycinate (75mg) eq. to Elemental Iron 15mg + Folic acid IP 0.25mg + Vitamin B 12 IP 3.75mcg +Zinc Picolinate (26mg) eq. to Element Zinc 5.5 mg Syrup Iron Dextran Glycoside 100mg (5 & 10ml Ampoule) June-1967 Iron Polymaltose (2ml=100mg Fe) Ampoule April-1963 Iron polymaltose (40mg of elemental iron in a complex of) + Vit. B6- 2mg + Vit. B12 40mcg tablet Feb-77 Iron polymaltose aq. Solution (50mg of elemental iron in a complex of) + Vit. B6 2mg + Vit. B12 Feb-77 5mcg Syrup Iron Sorbitol Citric Acid Complex (eq. To Iron) 50mg/ml Injection September-1969 Iron Sorbitol Citric Acid Complex (Injection of colloidal iron) January-1969 Iron Sucrose Complex i.v Injection 2-1-1999 Iron-Sorbitol Citric Acid Complex 2ml Injection May-1962

PHARMADOCX CONSULTANT 58 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Irsogladine Maleate Tablet 2mg 05-06-2010 /4mg Isepamicin Sulfate 100mg/250mg per ml Injection 26-12-1997 ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) 19.03.08 ISMN 30mg SR + Atenolol 50mg tablets (Additional Strength) 19.03.08 ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets 02.01.08 (Additional Strength) ISMN 30mg SR + Metoprolol Succinate equivalent to metoprolol tartrate 25mg/50mg tablets 02.01.08 (Additional Strength) ISMN 60mg Sr + Atenolol 50mg/100mg 23.03.07 ISMN 60mg/60mg SR + Atenolol 50mg/100mg film coated tablet 23.03.07 ISMN SR 30mg + Aspirin75/150mg tablet (addl. Strength). 20-07-2006 ISMN SR 30mg/30mg + Aspirin75/150mg film coated tablet(addl. Strength) 20-07-2006 ISMN SR 60mg + Metoprolol Succinate ER 25/50mg 10-8-2006 ISMN SR 60mg/60mg + Metoprolol Succinate ER 25/50mg film coated tablet 08-10-2006 Iso propyl Alcohol IP ……75% v/v 07.07.2017 Hydrogen Peroxide IP …....0.125% v/v Glycerol IP…….1.45% v/v Solution Each 100ml contains: Iso propyl Alcohol IP ……75% v/v 07.07.2017 Hydrogen Peroxide IP …....0.125% v/v Glycerol IP…….1.45% v/v Solution Each 100ml contains:

Isocarboxacid 10mg Tablet July-1962 Iso-dihydo-ethaverine chloride April-1965 Isoflupredone AcetateSuspension for Injection (2mg per ml) ( For Veterinary) 03.10.09 Isoflurane July-1990 Isometamidium Chloride (For Veterinary) January-1977 Isoniazid 300mg+Ethambutol 800mg+Vitamin B6 10mg tablet 20.01.2000 Isopregnenone (Dydrogestrone) 5mg Tablet August-1962 Sulphate (2mg/ml) Injection April-1970 Isoprenaline Sulphate April-1970 Isopropamide iodide 5/10mg Tablet March-1961 Isopropamide Hcl. Capsule February-1967 Isopropyl Thioimidazolidine 5mg Tablet December-1972 Isopropyl Unoprostone 25-11-2003 Isoptin Hydrochloride 5mg/2ml Injection September-1974 Isosorbibe 20 mg + Hydralazine 18.09.2009 37.5 mg tablets Isosorbibe 20mg + Hydralazine 37.5mg tablets 18.09.2009 Isosorbide Dinitrate 5mg/10mg Tablet October-1967 Isosorbide-5-Mononitrate 25mg/50mg/40mg SR Tablet May-1991 IsosorbideMononitrate 20mg/40mg/10mg Tablet August-1985 Isosorbid-mononitrate (SR pellets) 60mg+Aspirin 75mg Capsule 16.07.2002 Isotretinoin 0.05% + Erythromycin 2% gel 08.06.07 Isotretinoin 0.05% + Erythromycin 2% gel 08.06.07 Isotretinoin Gel (0.05%) 11-10-2004 Isotretinoin Soft Gel Cap. 21.06.2002 10mgTablet & Ampoule March-1961 Isoxsuprine Hydrochloride 40mg Sustained Release Tablet April-1979 Isphghula 3.5gm + Lactitol 10gm per 15gm Sachet 25.10.2010 Itopiride Capsules 09.05.2002 Itopride 150mg capsule (S.R) 22-05-2006 Itraconazole 100mg Capsule 20-7-1993 Itrolan 190 (0.406g/ml), Itrolan 240 (0.513g/ml), Itrolan 300 (0.641g/ml) Injection 23-10-1992 Ivabradine (Hcl.) 5mg/7.5mg Tablets 03.07.08

PHARMADOCX CONSULTANT 59 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Ivabradine Hcl Tablets 5/7.5mg (Additional Indication) 10-02-2010 Ivabradine HCL Tablets 5mg/7.5mg (Additional indication) 19.12.13 Ivabradine Tablets 5mg/7.5mg (Additional 05-05-2011 Indication) Ivermectin 1% w/v Injection (For Veterinary) October-1985 Ivermectin 10% w/v Concentrate Solution (For Veterinary) October-1985 Ivermectin IP 2 mg + Praziquantel IP 50 mg (veterinary product) Each uncoated tablet Contains: 17.11.14 Ivermectin IP 10 mg+ Clorsulon USP 100 mg (veterinary product) Each ml of injection contains: 07.08.14 Ixabepilone lyophilized powder (additional Indication) 09.10.08 Ixabepilone lyophilized powder inj. 15mg/45mg per vial 13.09.08 Kanamycin Sulphate Vials of 2cc (0.5gm) December- 1961 Ketamine Hydrochloride August-1971 Ketoconazole 2% + Zinc Pyrithone 1% Lotion 23.02.09 Ketoconazole 2% + 23.02.09 Zinc Pyrithone 1% Lotion Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution 09.02.09 Ketoconazole 2% w/v + Prepared Coal Tar 2% w/v (I.P. 1966) Solution 09.02.09 Ketoconazole 200mg Tablets September-1986 Ketoconazole 20mg/ml Suspension September-1986 Ketoconazole IP 1.0 %w/w + Chlorhexidine Gluconate Solution IP Eq. to Chlorhexidine Gluconate 30.04.15 2.1 % w/w shampoo for topical use. (veterinary product) Ketoprofen 30mg Transdermal Patch 17-5-1999 Ketoprofen 50mg Tablets/Capsules April-1981 Ketoprofen BP 100mg Controlled Release Capsule July-1989 Ketoprofen plaster 30 mg (7cm X 10 cm) 11.12.2009 Ketoprofen Plaster 30mg (7cm X 10cm) 18.4.12 Ketoprofen Plaster 09.03.11 ( Size - 7cm x 10 cm) Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops 24.07.08 Ketorolac ODS 10mg (Additional Dosage form) 29.04.15 Ketorolac Tromethamine 0.4% w/v 21.09.10 +Moxifloxacin 0.5% w/v Opthalmic solution (Additional strength) Ketorolac Tromethamine 0.4% Eye drops (addl. Strength) 20-09-2005 Ketorolac Tromethamine 0.4% w/v 21.09.10 +Moxifloxacin 0.5% w/v Opthalmic solution Ketorolac Tromethamine 0.5% Sterile Ophthalmic Solution 1-3-1996 Ketorolac Tromethamine 10mg Film Coated Tablet 21-4-1992 Ketorolac Tromethamine 30mg/ml & 15mg/ml (i.m) Injection 21-4-1992 Ketorolac Tromethamine 4mg + Gatifloxacin 3mg Eye Drops 24.07.08 Ketorolac Tromethamine 5mg + Ofloxacin 3mg per ml Eye drops 12-07-2005 Ketorolac Tromethamine 5mg + Ofloxacin 3mg/ml Eye drops 07-12-2005 Ketorolac Tromethamine Gel 2%w/w 31.03.09 Ketorolac Tromethamine IP 4.00mg + Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium 21.11.11 Chloride IP 0.05mg Ophthalmic solution Ketorolac Tromethamine IP 4.00mg + 21.11.11 110. Olopatadine Hcl eq. to Olopatadine 1.00mg + Benzalkonium Chloride IP 0.05mg Ophthalmic solution Ketorolac Tromethamine Ophthalmic Solution 0.45% 10-02-2010 Ketotifen Fumerate 0.25mg/ml Eye Drops 5-5-2000 KFD Vaccine (Kyasanur Forest Disease) March-1989 Kitotifen Fumerate 1mg Tablet May-1991 Kitotifen Fumerate Syrup Ketotifen Fumerate Nasal Drops Korsolex Concentrated Instrument Disinfectant 20-5-1992

PHARMADOCX CONSULTANT 60 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

L- Isoleucine 0.335gm+ L-Lencine 0.500gm+L-Valine 0.380gm+L- Lysine 0.550gm+ L-Methionine 23.04.2002 0.120gm+ L- Pnenylalanine 0.210gm+ L-Threomine 0.185gm+ L-Tryptophan 0.100 + L-Ariginine 0.420gm+ L-Histidine 0.190gm+L-Alanine 0.400gm+L-aspartic acid 0.300gm+L-Lystine 0.095gm+L-Glutanic acid 0.500gm+Amino acetic acid IP 0.200gm+L-proline 0.150gm+L- serine 0.200gm+L-Tyrosine 0.45gm+L- ornithine Hcl 0.144gm+Taurine 0.030gm per 100 ml injection L- Lysine Hcl Ointment (150mg/gm) 8-8-2006 Labetolol Hydrochloride December-1986 Labetolol Hydrochloride 50mg/100mg/200mg Tablet January-1987 Lacidipine 2mg/4mg Film Coated Tablet 5-5-1997 Lacosamide film coated tablet 50mg 10-06-2010 /100mg /150mg /200mg Lacosamide Injection 10mg/ml 19.10.12 Lacosamide Syrup15mg/ml(Additional 02-05-2011 Dosage Form) Lacti syn conc. Ampoule June-1965 Lactic acid 1.0% w/v+ Lactoserum 0.9% w/v (for topical use) 06.11.1995 Lactitol monohydrate Syrup 66.67/100ml 14.05.07 Lactitol Sachet (10gm/20gm). 21-11-2005 Lactobacillus Sporogenes 50/100million Tablet October-1971 Lactobacillus brevis CD2 Lozenges 100mg (corresponding to not less than 1 billion) of live, 9-8-2014 lyophilised, lactic acid bacteria, Lactobacillus brevis CD2. (Additional indication) Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 4.11.2009 20 mg sachets & capsules Lactobacillus Rhammnosus 1 billion cells + Saccharomyces Boulardi 125 mg + Zinc Enriched yeast 4.11.2009 20 mg sachets & capsules Lactulose 10 gm + Ispaghula husk 3.50 gm granules Each 15 gm sachet contains: 16.05.2009 Lactulose 10 gm 16.05.2009 + Ispaghula husk 3.50 gm granulesEach 15 gm sachet contains: Lactulose Enema (20%) 28-03-2006 Lafutidine Tablets ....5mg/10mg. 11.11.2009 Lamivudine (40mg) +Stavudine (10mg) per 5ml) reconstituted solution 04-08-2005 Lamivudine (40mg) +Nevirapine (70mg +Stavudine (10mg) per 5ml powder for suspension 28-01-2005 Lamivudine (40mg) +Nevirapine (70mg 28-01-2005 +Stavudine (10mg) (in 5ml) powder for suspension Lamivudine (40mg) +Stavudine (10mg/5ml) reconstituted solution 08-04-2005 Lamivudine 150mg + Stavudine 40mg + Efavirenz 600mg Combikit Tablet 06.08.2005 Lamivudine 150mg + Zidovudine 300mg + Efavirenz 600mg Combipack 06.08.2005 Lamivudine 150mg+Zidovudine 300 tablets 26.11.1999 Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet 08-11-2006 Lamivudine 20mg + Nevirapine 35mg + Stavudine 5mg tablet 11-8-2006 Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength) 01.04.08 Lamivudine 20mg + Stavudine 5mg dispersible tablets (Additional Sgtrength) 01.04.08 Lamivudine 25mg/5ml Oral Solution 30-12-1999 Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet 14-06-2005 Lamivudine 30/60mg + Stavudine 6mg/12mg + Nevirapine 50mg/100mg dispersible tablet 14-06-2005 Lamivudine 300 mg (E.R) + Zidovudine 600 mg (E.R) + Nevirapine 400 mg tablets FDC of 15-07-2004 Lamivudine 300mg + Abacavir 600mg Tablets 06.07.2005 Lamivudine 30mg + Zidovudine 60mg 23.02.09 +Nevirapine 50mg Oral Suspension (Tablets for oral Suspension) Lamivudine 30mg 23.02.09 + Zidovudine 60mg +Nevirapine 50mg Oral Suspension (Tablets for oral Suspension) Lamivudine 40mg + Stavudine 10mg dispersible tablet. 07-12-2006 Lamivudine 40mg + Stavudine 10mg dispersible tablet. 12-7-2006 Lamivudine IP 30mg Zidovudine IP 60mg (Additional strength) Each dispersible Tablet contains: 15.02.2017

PHARMADOCX CONSULTANT 61 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Lamivudine150mg/100mg Uncoated Tablet 27-3-1998 Lamivudine 50mg/25mg per 5ml Oral Solution Lamivudine150mg+ Zidovudine 300mg+Abacavir as sulphate 300mg tablet 03.10.2003 Lamotrigin 200mg tablet (addl. Strength) dispersible tablet (5mg/50mg/100mg/200mg 06-08-2006 Lamotrigin 200mg tablet (addl. Strength) dispersible tablet 5mg/50mg/100mg/ 200mg 8-6-2006 Lamotrigine 25mg Modified Release Tablet (Addl. Strength) 05-04-2010 Lamotrigine 25mg Tablet 14-5-1998 Lamotrigine 50mg/100mg Tablet 21-1-2000 Lamotrigine ER Tablet 25mg/50mg/100mg/200 mg 06.08.12 Lamotrigine MR Tablets 150mg (Addl. Strength) 3.10.2009 Lamotrigine MR Tablets 50/100mg 17.12.08 Lamotrigine Orodispersible Tablet 20-03-2010 12.5 mg(additional strength) Lamotrigine S.R. tablet 50 mg/100 mg/200 mg 26-08- 2004 Lansoprazole 15mg/30mg (as enteric coated granule) Capsule 16-12-1994 Lansoprazole for injection 30mg/vial 28.04.08 Lanthanum Carbonate Chewable tablet (250mg/500mg) 09-11-2005 Lapatanib tablet 250mg (Additional indication) 22.12.14 Lapatinib (as Ditosylate) (250mg) Tablet. 24-07-2007. Lapatinib Ditosylate Tablets 250mg (addl. Indication) 10-05-2010 L-Asparaginase May-1973 Latanoprost 50mcg+ Timolol maleate eq. to Timolol 50mg each ml eye drops 02.08.2002 Latanoprost 0.005% W/v +Timolol maleate 0.5% W/v (Presevative free) Opthalamic Solution 10.09.13 (Additional Dosage Form) Latanoprost 50mcg/ml Eye Drops 12-5-1998 Latanoprost 50mcg/ml Ophtalamic Solution 02-06-2011 (Additional Indication) L-Carnitine 330mg Capsule, L- Carnitine 250mg Tablet & L- Carnitine 1gm/10ml Oral Solution June-1990 L-Dihydroxyphenylalanine 500mg Capsule/Tablet May-1971 Lecithin Liquid (each 5 ml contains lecithin 500mg equivalent to essential phospholipids 250mg 14.05.08 Ledipasvir (90mg)+ Sofosbuvir (400mg) Tablet 08.12.2015 Ledipasvir 90mg + Sofosbuvir 400mg 08.12.2015 Tablet Ledipasvir 90mg + Sofosbuvir 400mg 08.12.2015 Tablet Ledipasvir Bulk 08.12.2015 Leflunomide 01.10.2001 Lenalidomide capsule (5mg/10mg/15mg/25mg) 16.05.07 Lenalidomide Capsule 5mg/10mg/15mg/25mg (Additional Indication) 22.04.08 Lenvatinib 4mg/10mg Hard Gelatin Capsules (Lenvatinib Mesylate) 02.12.2016 Leprosy Immunomodulator Vaccine (based on MW) 9-2-1999 Lercanidine HCl 07.05.2002 Lercanidipine 10mg + Atenolol 50mg Tablet 17.10.2003 Letrozole 2.5mg Film Coated Tablet 12-3-1998 Letrozole 2.5mg tablet (for additional indication) 10.04.07 Leuprolide Acetate 3.75mg per vial Depot for Injection 10-12-1997 Levamisole 18.2% w/v Injection July-1980 Levamisole 50 mg+Mebendazole 200mg tablet Sep-84 Levamisole HCl IP 1.5 g eq to levamisole 1.27 g + Oxyclozanide IP 2.0 g + Anhydrous Copper 21.08.15 Sulphate BP eq to elemental copper 18.75 mg + Zinc sulphate monohydrate USP eq to elemental Zinc 6.0 mg + Cobalt sulphate eq to elemental cobalt 2.25 mg (veterinary product) Each Bolus (Tablet) contains:

Levamisole HCl IP 2.0gm + Oxyclozanide IP 4.0gm 08.06.15 (veterinary product) (Additional strength) Each Bolus contains:

PHARMADOCX CONSULTANT 62 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Levamisole Hydrochloride 15% w/w & 30% w/v Mixture July-1980 Levamisole hydrochloride IP 15.0% w/w Eq. to Levamisole 12.7% w/w + Anhydrous Copper 30.04.15 Sulphate BP Eq. to elemental Copper 0.16% w/w + Zinc Sulphate Monohydrate USP Eq. to elemental Zinc 0.05% w/w + Cobalt Sulphate Eq. to elemental Cobalt 0.02% w/w soluble powder for oral use. (veterinary product) Levamisole-1.5%+Oxyclozanide-3.0% Suspension 29.09.1993 Levetiracetam (250mg,500mg, 04-04-2005 750mg) Tablets Levetiracetam Oral Solution (100mg/ml) 22-09-2005 Levetiracetam Oral Solution (100mg/ml). 24-02-2006 Levetiracetam Oral Solution 100mg/ml 05-05-2011 (Additional Indication) Levetiracetam SR Tablet 500/750/1000mg 2.05.2009 Levetiracetam Tablet (addl. indication) 09-10-2007. HCl Opthalmic Suspension 0.5% 16-01-2010 Hcl USP 2.5mg/5.0mg per ml Ophthalmic Solution 16-5-1996 Levo-Carnitine 1gm per single dose (5ml ampoule) Injection 31-3-2000 Levocetirizem 2Hcl. Dispersible tablet (2.5mg) 08.05.07 Levocetirizine 2.5mg + Montelukast 4mg Dispersible Tablet & Syrup 13.01.2010 Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule FDC of 29-07-2005 Levocetirizine dihydrochloride 2.5mg 13.10.10 +Montelukast 5mg dispersible tablet Levocetirizine HCl 2.5mg/5mg+ Pseudoephodrine HCl SR 120mg/120mg tablet 29.01.2004 Levocetirizine (5mg) + Ambroxol (75mg S.R) Capsule FDC of 29-07-2005 Levocetirizine Di-HCl mouth dissolving tablets (5mg) (new dosage form). 25-07-2007. Levocetirizine Di-HCl syrup (2.5mg/5ml) (for use in children 2 years and above). 26-09-2007. Levocetirizine Di-HCl Syrup2.5mg/5ml 05-05-2011 (Additional Indication) Levocetirizine dihydrochloride 2.5mg +Montelukast 5mg dispersible tablet 13.10.10 Levocetirizine Dihydrochloride IP 2.5mg/2.5mg/5mg + Montelukast Sodium IP Eq. to Montelukast 30.04.15 4mg/5mg/10mg orally disintegrating strip.(Additional dosage form) Levocetirizine ODS 2.5mg /5mg (Additional 14.01.15 dosage form) Levocetirizine Syrup (2.5mg/5ml) 13-01-2005 Levocetrizine 12.12.2002 Levocetrizine 2.5/5mg + Ambroxol 30mg/30mg per 5ml of syrup 20-07-2006 Levocetrizine 2.5/5mg + Ambroxol 30mg/5ml of syrup 20-07-2006 Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet 24-05-2006 Levocetrizine 5mg + Ambroxol Hydrochloride SR (75mg) tablet 24-05-2006 Levocetrizine Di HCl Dispersible tablet 5mg/10mg (New Dosage form) 28.01.08 Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR 08-09-2006 Capsules Levocitirizine 2 Hcl 5mg+ Ambroxol Hcl SR 75mg + Pseudoephedrine Hcl 120mg SR Capsules 9-8-2006 Levocloperastine ( as Fendizoate) Suspension eq. to Levocloperastine Hcl 20mg / 5ml. 29.09.10 Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) 25-07-2005 tablet Levodopa (50mg/100mg/150mg) + Carbidopa (12.5mg/25mg/37.5mg + Entacapone (200mg) tablet 25-07-2005 Levodopa 100/100/250 + Carbidopa10/25/25mg mouth dissolving tablet 04.03.09 Levodopa 100/100/250 04.03.09 + Carbidopa10/25/25mg mouth dissolving tablet Levodopa 100mg/200mg+Benserazide 25mg/50mg each capsule Nov-85 Levodopa 100mg/250mg + Carbidopa 10mg/25mg Tablet/Capsules 02.09.1988 Levodopa 200mg + Carbidopa 50mg C.R. tablet 08.01.08 Levodopa 200mg + Carbidopa 50mg C.R. tablet 08.01.2008 Levodopa+Carbidopa Dec-83 Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup 06.07.2009

PHARMADOCX CONSULTANT 63 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Levodropropizine Eur. Ph. 30mg + Chlorpheniramine maleate IP 2mg per 5 ml Syrup 06.07.09 Levodropropizine oral suspension (30mg/5ml) 25-02-2005 levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet 08.02.07 Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml eye drops. 11-07-2007. Levofloxacin (15mg) + Prednisolone Acetate 10mg per ml eye drops. 11-07-2007. levofloxacin (250mg/500mg) + ambroxol SR 75mg tablet 08.02.07 Levofloxacin 0.5% Ear drops 27-06-2006 Levofloxacin 250mg/500mg Film Coated Tablet Levofloxacin 5mg/ml (in 50ml & 100ml) Infusion 26-7-1999 Levofloxacin Oph. Solu. (1.5%) 15mg/ml. (Addl. Strength). 16-12-2005 Levofloxacin Ophthalmic Solution (0.5%) 04-03-2005 Levofloxacin Oral Solution (each 240ml bottle contains Levofloxacin 125mg/5ml.) 07.03.07 Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional indication) 26-09-06 Levofloxacin tablet (250mg /500mg) & Infusion 5mg/ml (For additional indication) 26-09-06 Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet 13.10.10 Levonorgesterel 100mcg +Ethniyl estradiol IP 20mcg tablet 13.10.10 Levonorgestrel 0.03mg tablet 23.03.07 Levonorgestrel 0.25mg+Ethinyl Estradiol 0.05mg tablets 07.06.2001 Levonorgestrel 1.5mg tablets 07.02.07 Levonorgestrel 52mg Sterile Intra Uterine System 13-9-2000 MDI (50mcg/actuation) & Dry Powder inhaler (100mcg/capsule) (New Dosage 16.03.07 Form) Levosalbutamol rotacaps (100 mcg/capsule) & inhaler (50 mcg /actuation) 20-10-2004 Levosalbutamol Tablet 1 mg/2mg 16-07-2004 & Syrup 1 mg/5 ml. Levosimendan Injection 2.5mg / ml 30-04-2010 Levosulpiride 75/150/200 mg (add. 9.12.14 Strength) Levosulpiride Inj. 25mg/ml, 2ml 26.09.08 Levosulpiride tablet (25mg) 10.05.07 Levosulpiride Tablet (50mg/100mg) (addl. strength for addl. indication). 12.6.07 Levosulpride (SR) 75mg + Rabeprazole sodium IP (EC Pellets) 20mg Capsule 19.08.11 Levosulpride (SR) 75mg + Rabeprazole 19.08.11 sodium IP (EC Pellets) 20mg Capsule Levosulpride ER Tablet 100/150/200mg 27.10.2009 Levosulpride Injection 25mg/2ml (Additional 17.12.08 Strength) Levovist 4gm & 2.5gm granules per 20 ml vial(1gm granules contains Galactose 999mg + Palmetic 28.11.1997 acid 1 mg) Licomycin 50mg + Spectinomycin 100mg for vetarnary use Oct-88 Lidocaine 2%+Prilocaine 2.5% w/w cream May, 1999 Lidocaine 2.5% w/w+Prilocaine 2.5% w/w Gel (additional strength) 26-03-2010 Lidocaine 2.5% w/w+Prilocaine 26-03-2010 2.5% w/w Gel Lidocaine HCl Ophthalmic Sterile Gel 35 mg/ml 30-07-10 Lidocaine Lozenges 100mg (Additional Strength) 15-07-10 Lidocaine Lozenges 200/300mg 26.02.09 Lidocaine Lozenges 200/300mg (Addl. Indication) 19.08.2009 Lidocaine Patch 350mg (Additional Pack Size) 17-06-2010 Lidocaine Patch 700mg in aqueous base. (50 mg per gram adhesive) 26.03.09 Lidocaine7.5mg + Prilocaine2.5mg per acutation spray 03-12-2010 Lidocaine7.5mg + Prilocaine2.5mg per acutation spray 12-03-2010 Lidoflazine 60mg Tablet November-1974 Lignocaine 50mg + Aluminium Hydroxide 300mg + Magnesium hydroxide 100mg + Activated Sep-78 dimethicone 20NF 50mg Tablet & 5 ml suspension Lignocaine(base) 2%+ Silver Sulphadiazine 1%+ Chlorhexidine Glulonate 02% cream 18.06.1996 Linagliptin 2.5mg/2.5mg/2.5mg + Metformin 500mg/850mg/1000mg 26.07.13 Film coated Tablets

PHARMADOCX CONSULTANT 64 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Linagliptin film coated Tablet 5mg 23.01.12 Lincomycin 300mg + Neomycin 200mg + Methyl Prednisolone 5mg per 10ml Infusion Solution Mar-89 Lincomycin Hcl (eq. to Lincomycin base) 250mg/5ml Syrup June-1973 Lincomycin Hcl 2% w/w Gel 11-5-2000 Lincomycin Hcl. 500mg Tablet August-1968 Lincomycin Hydrochloride 500mg Capsule December-1972 Linezolid 04.10.2001 Linezolid (600 mg) Tablet 30-05-2004 Linezolid 2mg+Dextrose-5% per ml injection 01.04.2002 Lipid Based Amphotericin-B Gel 0.1% 05-02-2010 Lipoproteins Extracted from Human Placenta 50% Lotion January-1989 Liposomal Doxorubicin Hcl 2mg/ml Pegylated Injection 29-11-2000 Liposomal Amphotericin B Injection 50mg/vial (Additional Dosage Form) 02.08.2016 Liquid paraffin 6% + White soft paraffin 15%w/v Cream 29-04-2010 Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate 3.33mg per 5ml 29.01.09 Liquid paraffin 6% + White soft paraffin 15%w/v Cream 29-04-2010 Liquid Paraffin1.25ml + Milk of Magnesia 3.75ml + Sodium Picosulphate3.33mg per 5ml 29.01.09 Lisinopril Dihydrate 10mg/20mg/2.5mg/5mg Tablet November-1991 Lisinopril 10mg/20mg/5mg+Hydrochlorothiazide 12.5mg/25mg/12.5mg uncoated tablet 23.11.1995 L-Isoleucine 9.20mg+L-Leucine HCL 9.45mg+L- Methionine 0.395mg+L- Phenylalanine 0.44mg+ 26.06.2008 L-Threonine0.30 mg+L-Tryptophen 2.14mg + L-Valine 0.70mg+ L-Alanine 8.90mg+ L-Arginine 8.40mg + L- Aspartic Acid 15.37mg+L histadine 0.20mg+ L- Proline 3.10mg +L-Serine 5.30mg+L- tyrosine 2.60mg+Glycine 0.40mg +WFI per 100ml Lithium Carbonate August-1969 Lithium Carbonate 250mg Capsule November-1972 Lithium Carbonate 300mg Capsule June-1970 Lithium Carbonate ER (450mg) tablet 28-06-2004 Live freeze-dried lactic acid bacteria and bifidobacteria capsules 10.04.08 Livetiracetam conc. for infusion 100mg/ml (new dosage form) 21.05.07 Lixisenatide pre-filled solution for injection 10µg/20 µg 15.01.2015 Lofepramine 35mg/70mg Tablet January-1990 Lomefloxacin 400mg Tablet 20-5-1994 Lomefloxacin Hcl 3mg/ml Eye Drops 22-7-1998 Lomustine 10mg/40mg/100mg Capsule August-1980 Loperamide December-1976 Loperamide Bulk October-1978 Loperamide Hcl 2mg+Simethicone 125mg tablet 16.10.2001 Lopinavir + Ritonavir (100 + 25mg) Tablets (additional strength) 08.09.08 Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) 06-08-2006 Lopinavir + Ritonavir 16.01.2004 Lopinavir + Ritonavir (100 + 25mg) Tablets (additional strength) 08.09.08 Lopinavir 200mg + Ritonavir 50mg Tablet (addl. Strength) 8-6-2006 Lopinavir 40mg 12.06.2017 Ritonavir 10mg oral pellets (capsules) (Additional strength)Each capsule contains: Lopinavir 80mg + Ritonavir 20mg per 5 ml oral solution, Lopinavir 133.3mg + Ritonavir 33.3 mg 18.01.2001 Capsule Loratadine 10mg+Psendoephedrine sulphate in ER form 180mg film coated Tablet 17.09.1999 Loratidine 10mg Tablet 19-6-1992 Loratidine 5mg+Pseudoephedrine 120mg (ER) tablets 21.08.1996 Lorazepam September-1973 Lorazepam 1mg/2mg Tablet December-1973 Lorazepam Orodispersible Tablet 1mg/2mg 29.05.15 (additional Dosage form) Lornoxicam 12 mg SR (additional strength) 26.6.2009 Lornoxicam 4mg + Paracetamol 500mg film coated tablets 05.02.09 Lornoxicam 4mg + Eperisone 50mg tablet 13.09.10 Lornoxicam 4mg + Eperisone 50mg tablet 13.09.10

PHARMADOCX CONSULTANT 65 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Lornoxicam 4mg + Paracetamol 500mg film coated tablets 05.02.09 Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets 02-12-2010 Lornoxicam 4mg/4mg + Thiocolchicoside 4mg/8mg tablets 12-02-2010 Lornoxicam 8mg /2ml inj. 12.11.07 Lornoxicam 8mg + Paracetamol 500mg Tablet 14.05.2009 Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets (additional strength) 23-03-2010 Lornoxicam 8mg/8mg + Thiocolchicoside 4mg/8mg Tablets 23-03-2010 Lornoxicam ER Tablet 8 mg (Additional Strength) 11.12.2009 Lornoxicam SR 16mg Tabs 25.04.2009 Lornoxicam tablet 4mg/ 8mg 21.05.07 Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets 15.09.08 Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength) 14.05.08 Losartan + Chlorthalidone (25/25/50/50mg + 6.25/12.5/6.25/12.5mg) Tablets 15.09.08 Losartan + HCTZ (100 mg + 25 mg) Tablets 10.11.08 Losartan + HCTZ (100 mg + 25 mg) Tablets 10.11.08 Losartan 100mg+ HCTZ 25 mg tablet 16.03.09 Losartan 100mg+ HCTZ 25 mg tablet 16.03.09 Losartan 25/25/50/50mg + Chlorthalidone 6.25/12.5/6.25/12.5mg FC Tablet 15.09.2008 Losartan 50mg + Atenolol 50mg 27.06.2005 Losartan Potassium 25mcg + Amlodipine (as besylate) 5mg tablets. (Additional Strength) 14.05.08 Losartan Potassium 25mg/50mg/100mg Film Coated Tablet 16-6-1998 Losartan Potassium 50mg+Hydrochlorothiazide 12.5mg film coated Tablet 08.06.1999 Losarten 50mg/50mg + Ramipril 2.5mg/5.0mg tabs 10.09.2003 Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution 14.02.07 Loteprednol etabonate 0.5% w/v + Moxifloxacin 0.5% w/v opthalmic Suspension 1.12.2009 Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) Eye drops. 12-07-2007. Loteprednol Etabonate (0.5%) + Levofloxacin (1.5%) Eye drops. 12-07-2007. Loteprednol etabonate 0.5% w/v 1.12.2009 + Moxifloxacin 0.5% w/v opthalmic Suspension Loteprednol Etabonate 5mg + Tobramycine 3mg per ml ophthalmic solution 14.02.07 Loteprednol Etabonate Nasal spray 0.1% w/v 31.01.09 Loteprednol Etabonate Ophtalmic Sol. 15.03.2002 Lovastatin (20mg) + Nicacin ER (500mg) tablet FDC of 20-12-2004 Lovastatin 10mg/20mg/40mg Tablet 5-10-1995 Lovastatin 20mg + Niacin 500mg ER form film coated Tablets 24.12.2004 Succinate 5mg/10mg/20mg/50mg Capsule and Loxapine 25mg/ml Oral Concentration September-1990 Solution Loxitalmic Acid April-1977 Loxoprofen Sodium tablet (60mg) 14.08.08 Lubiprostone Soft Gelatin Capsules 16.10.10 ..…8mcg /24mcg Luliconazole Cream 1% 3.06.2009 Luliconazole lotion 1 % W/V (new Dosage Form) 19-12-2011 Lumiracoxib Tablet (100/200/400mg). 1-8-2006 Luprostiol 7.5mg per vial Injection (For Veterinary) June-1986 Hydrochloride Bulk & Lurasidone Hydrochloride Tablets 40mg/80mg 18.07.16 Lutin 0.1gm + Vit 0.1gm + Vit K1 2.5mg + Dicalcium Phosphate 0.1gm + Carlozochrome Jul-69 Salicylate 1mg tablet Lymecycline October-1962 Lymecycline (eq. To Tetracycline) 300mg Capsule October-1978 Lynestrenal 0.75mg + Ethinylestradiol 37.5mcg tablet Apr-79 Lynestrenal 1mg + Ethinylestradiol 50mcg tablet Sep-73 Lynestrenol January-1964 Lynestrenol B.P 0.5mg Tablet March-1975 Lynestronol 2.5mg + Ethinyloestradiol 50mcg Sep-70 Lynestronol 2.5mg + Mestranol 0.075mg Tablet Apr-67

PHARMADOCX CONSULTANT 66 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Lyophillized S.boulardii- 282.5mg Sachet 18-12-1997 Lyophillized S.boulardii- 282.5mg Capsule Maduramicin Amonium 10gm 7-7-1993 Maduramicin Amonium 0.5% (1% Premix) (For Veterinary) Magestrol Acetate Tablet April-1964 Magnesium Valporate Prolonged release tablet 600mg 4.06.2009 Magnesium Valproate CR Tablet 200/ 300/400/ 500 mg (additonal strength) 26-03-2010 Magnesuim Valproate Tablet 200mg/400mg 04.12.08 Malathion 0.5% Lotion September-1975 Malathion 1% Dusting Powder December-1973 Marantel Tartrate August-1973 Maraviroc Tablets 150mg/300mg. 25.11.2009 Marcaine 0.25% with & without adrenaline and Marcaine 0.5% with or without adrenaline September-1972 Marek's Disease Vaccine T.H.U Living (For Veterinary) April-1972 Measles (Edmoustan zagreta strain) Mumps and Rubella Vaccine December-1987 Measles Mumps & Rubella Vaccine February-1983 Measles Virus Vaccine Live Attenuated April-1965 Mebendazole 100mg/5ml Suspension December-1978 Mebendazole 100mg Tablet December-1974 Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet 12-12-2006 Mebeverine Hcl 100mg Tablet October-1971 Mebeverine Hcl 135mg + Chlordiazepoxide 5mg tablet 12-12-2006 Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. 6-7-2006 Mebeverine HCl 135mg + Isabgula husk 3.5gm sachet. 07-06-2006 Mebeverine Hcl 50mg Tablet March-1971 Mebeverine HCl prolonged release capsule (200mg). 19-06-2007. Mebhydroline Napadisylate 50mg Tablet February-1964 Mebrophen Hydramine 25mg Tablet December-1969 Mebrophen Hydramine July-1965 Mecobalamin 0.5mg + Alpha Lipoic Acid 100mg + Benfotiamin 100mg + Pyridoxine 50mg fim 10.03.2008 coated tablet Mecobalamin 0.5mg+ Alpha Lipoic Acid 100mg+ Benfotiamin100mg + Pyridoxine 50mg tablets 03.07.08 Mecobalamin 0.5mg+ Alpha Lipoic Acid 100mg+ Benfotiamin100mg + Pyridoxine 50mg tablets 03.07.08 Mecobalamin 1000mcg + Vit B1 10mg + Vit B6 3mg + Folic Acid 1mg + Calcium Pantothenate 01.03.2008 50mg + Niacinamide 45mg tablets Mecobalamin 1000mcg+ Alpha Lipoic Acid 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ Inositol 19.03.08 100mg + Benfotiamine 100mg capsule Mecobalamin 1000mcg+ Alpha Lipoic Acid 200mg+ vitamin B6 3mg + Folic Acid 1.5mg+ Inositol 19.03.08 100mg + Benfotiamine 100mg capsule Mecobalamin 1500mcg + Alpha Lipoic Acid 100mg + B1 10mg + B6 3mg + Folic Acid 1.5mg 03.07.2008 capsules Mecobalamin 1500mcg + Alpha lipoic acid 100mg + Inositol 100mg + Vit.A 5000IU + Vit B1 25.02.2008 10mg + Pyridoxine 1.5mg + Vit E 25IU + Calcium Pantothenate 10mg + Folic Acid 1500mcg + Chromium 200mcg + Selenium 163.6mcg tablet Mecobalamin 1500mcg+ Alpha lipoic acid 100mg+ Vit B6 3mg + Folic acid 1.5mg + Zinc 15mg + 06.09.2008 Chromium 60mcg + Selenium 65mcg+ Biotin 100mcg + Inositol 2mg Tablet Mecobalamin 500mcg + Alpha Lipoic Acid 100mg + Folic acid 1.5mg + Benfotiamine 50mg Soft 13.11.2007 gelatin Capsules Mecobalamin 500mcg + Vit A 5000IU + Vit D3 400IU + Vit E 25IU + Vit B1 10mg +Riboflavin 03.07.2008 10mg + B6 3mg + Niacinamide 50mg+ Calcium Pantothenate 12.5mg + Vit C 100mg + Folic acid 1500mcg+ Biotin 60mcg + L- Glutamic acid 100mg + Dl-Methionine 25mg +Magnesium oxide 30mg + Manganese 2.5mg + Copper 2.5mg + Zinc 22.5mg + Chromium 100mcg + Selenium 60mcg tablets Mecobalamin 500mcg + Zinc Sulphate 61.8mg 29.11.2007 + Calcium Patothenate 10mg + Pyridoxine 3mg + Folic Acid 1.5mg + Niacinamide 50mg + Chromium 50mcg Tablets Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets 16-03-2010

PHARMADOCX CONSULTANT 67 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Mecobalamin 750 mcg + Pyridoxine 1.5mg + Nicotinamide 45 mg + Benfotiamine 150mg Tablets 16-03-2010 Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg + Nicotinamide 45 mg tablets 27.10.2009 Mecobalamin 750 mg + Pyridoxine Hydrochloride1.5 mg 27.10.2009 + Nicotinamide 45 mg tablets Mecobalamin0.5mg + Pyridoxine 50mg + Benfotiamine100mg capsule 29.11.07 Mecobalamin0.5mg + Pyridoxine 50mg + Benfotiamine100mg capsule 29.11.07 Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calc 30.01.08 ium Pantothenate25mg+Folic Acid 1.5mg+Zinc oxide22.5mg+Chromium picolinate65mcg+Inositol10mcg+Lutein5mg capsule Mecobalamin1500mcg +Alpha Lipoic Acid100mg+Benfothiamine15mg+B63mg+Calcium 30.01.08 Pantothenate25mg+Folic Acid 1.5mg+Zinc oxide22.5mg+Chromium picolinate65mcg+Inositol10mcg+Lutein5mg capsule Mecobalamin500mcg + Alpha Lipoic Acid200mg + Benfotiamin 10mg + Pyridoxine3mg + 30.01.08 Biotin5mg + Folic acid 1.5mg capsule Mecobalamin500mcg + Alpha Lipoic Acid200mg + Benfotiamin 10mg + Pyridoxine3mg + 30.01.08 Biotin5mg + Folic acid 1.5mg capsule Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule 02.04.07 Mecobalamine 1500mcg + Alpha Lipoic Acid 200mg + Inositol 100mg + Folic Acid 1.5mg + 12.07.2007 Chromium Polynicotinate 200mcg + Seleno Methionine 55mcg + Zinc Monomethionine 25mg Capsule Mecobalamine 1500mcg + Alphalipoic Acid 100mg + Thiamine mononitrate 10mg + Pyridoxine 29.11.2007 3mg + Folic Acid 1.5mg Capsule Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5/1.5mg 39275 + Chromium Polynicotinate 65mcg/200mcg+ Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule Mecobalamine 500/1500mcg + Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5/1.5mg 12-07-2007 + Chromium Polynicotinate 65mcg/200mcg+ Selenium Dioxide18/55mcg + Benfotiamine 50/150mg capsule Mecobalamine 500mcg + Alpha Lipoic acid 100mg soft gelatin capsule 02.04.07 Mecobalamine 500mcg+ Alpha Lipoic Acid 100mg + Inositol 100mg + Folic Acid 0.5mg + 12.07.2007 Chromium Polynicotinate 65mcg + Selenium Dioxide 18mcg Capsules Mecobalamine E.R. tablet (1500mcg) 19-07-2005 Medicated Pad with Cetylpyridinium Chloride 0.3% w/w each perforated fresh coloured Self 6-10-1994 Adhesive Plaster Strip Medoxyprogesterone Acetate Suspension for Injection 104mg/0.65ml Subcutaneous Route. 12.08.2016 (Additional Indication) Medronic acid 10 mg + Stannous chloride. 2H2O-1mg per vial injection 23.02.1999 Medroxy Progesterone Acetate Tablet June-1986 Medroxyprogesterone acetate suspension for injection s.c . Single dose container with 104mg 18.12.14 Medroxyprogesterone acetate in 0.65 ml suspension for injection (SAYNA PRESS) (Additional route/ strength/indication) Medrysone USP 1% Ophthalmic Suspension July-1980 Mefanamic Acid January-1976 Mefenamic acid 500mg+Tizanidine 2mg 12.07.2002 Mefloquine Hcl 250mg Film Coated Tablet 3-3-1997 Megaldrate 400 mg+Simethicone 60 mg per 5ml Suspension Nov-82 Megaldrate 400 mg+Simethicone 60mg chewable tablet Nov-82 Megaldrate 400mg Tablet November-1982 Megestrol Acetate Oral Suspension 400mg per 10ml (10 & 20mg Sachet) 5.12.12 Meglumine & Sodium salt of loxitalanic acid 62.5% September-1977 Meglumine gadoteric 16.10.2002 Meglumine iocarmate February-1974 Meglumine Iothalamate August-1965 Meglunine Ioxaglate sodium + Sodium Ioxaglate injection 16.08.2001 Melagenina Lotion May-1988

PHARMADOCX CONSULTANT 68 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Melatonin 3mg Tablet 12-3-1998 Meloxicam 7.5mg/15mg Uncoated Tablet 16-2-1999 Meloxicam Inj. (Vet) 02.04.2002 Meloxicam ODT 7.5mg /15 mg(Additional dosage form) 23.02.15 Melphalan October-1964 Memantine 5mg /10mg + Donepezil 5mg Tablets 31.01.08 Memantine 5mg /10mg + Donepezil 5mg Tablets 31.01.08 Memantine ER Tablet 7mg/14mg/21mg. (Additional Strength) 17.12.2010 Memantine HCl tablet 5 mg/10 mg. 19-07-2004 Memantine HCl ER Tablet 28mg 06.09.10 Menadione Sodium Bisulphite 1mg/0.5ml Injection 6-8-1999 Mepatricin 50000 Units Enteric Coated Tablet 28-5-1993 Mepenzolate methylbromite 25mg Tablet March-1961 Meropenem IP 1000mg + Sulbactam sodium USP 500mg injection 15.03.11 Meropenem Inj. 08.01.2002 Meropenem Injection IP 500mg/1.0g 20-05-2011 (Additional Indication) Meropenem IP 1000mg + Sulbactam 15.03.11 sodium USP 500mg injection Mesalamine Delayed Release Tablets 800 mg (Additional dosage form) 11.04.2017 Mesalamine PR Tablets 1.2gm 30.03.09 Mesalazine (5-Amino Salicylic Acid) 250mg/400mg Enteric/resin Coated Tablet & 4gm/60ml June-1989 Rectal Suspension Enema Mesalazine SR 04.04.2002 Me-salicylate 30% + Menthol 10% + camphor 4% Cream 29.11.07 Me-salicylate 30% + Menthol 10% + camphor 4% Cream 29.11.07 Mesna (Sodium-2-Mercapto- Ethane Sulphonate) December-1981 Mesterolone 10mg Tablet July-1974 Mesterolone 25mg Tablet March-1981 Mestranol 4mg + Ethinyloestradial 0.05mg Tablet May-67 Metadoxine 24-10-2003 Bitartarate (10mg/ml) 1ml & 10ml Vial January-1964 Metaxalone 08.10.2002 Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet 22-02-2005 Metaxalone (400mg) + Diclofenac Potassium (50mg) tablet 22-02-2005 Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets 28-05-2010 Metformin (ER )1000mg/500mg +Saxagliptin 19.09.11 2.5 mg/5mg Tablets Metformin (ER )1000mg/500mg 19.09.11 +Saxagliptin 2.5 mg/5mg Tablets Metformin 500/500mg + Repaglinide 1/2mg Tablet 20-08-10 Metformin 500/500mg + Repaglinide 1/2mg 20-08-10 Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg (Additional Indication) 02-08-10 Metformin 500/850/1000mg+Sitagliptin Phosphate 50/50/50mg Tablet(Additional Indication) 08-02-2010 Metformin 500mg CR + Glipizide 5mg CR Tablet 17.12.2003 Metformin ER tablet 750mg (Additional strength) 25.9.14 Metformin Hcl 500mg/850mg/1000mg+ Vildagliptin50mg/50mg/50mg Film coated Tablet ( 22.10.13 additional indication) Metformin Hcl 850mg + Sitagliptin Phosphate 50mg Tablet 15.12.2009 Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet 25.01.08 Metformin HCl ER 500mg + Fenofibrate 80mg/160mg tablet 25.01.08 Metformin HCl IP 500mg + Alpha Lipoic Acid USP 200mg Tablet 05.01.11 Metformin HCl IP 500mg + Alpha Lipoic 05.01.11 Acid USP 200mg Tablet Metformin Hcl. (0.5g) Tablet September-1961 Metformin Oral Solution (100mg/ml) 04-03-2005 Metformin SR 500mg/500mg + GliclazideSR 60mg/30mg + Pioglitazone 15mg/15mg tablets 28-05-2010

PHARMADOCX CONSULTANT 69 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Methacycline Hcl. December-1966 Methadone Hydrochloride 5mg/10mg per ml syrup; 5mg/ 10mg/ 20mg / 40mg tablet 28.05.09 Methadone Hydrochloride Oral Syrup 5mg/10mg per ml (in 150 ml pack) (additional indication) 10.05.2016 Methadone Hydrochloride tablet 5mg/10mg (additional indication) 10.05.2016 Methandienone 1mg/5mg Tablet February-1963 Methandienone BP 25mg + Benzyl alcohol in sterile solution 9% w/v/ml Apr-70 Methandienone Injection (Each ml contains; methandienone- 22.5mg to 27.5mg) September-1969 Methaqualone hydrochloride 150mg Tablet April-1961 Methdilazine 8mg Tablet & Syrup March-1961 Methenolone 1mg/5mg Tablet June-1962 & Injection Methicillin Sodium July-1980 Methimazole Tablet ( 5mg/10mg) 22-12-2005 Methocarbamol 1gm/1.5gm February-1961 I.V Injection & Tablet Methohexital Sodium 500mg Ampoule & 2.5gm Vial April-1964 Methophenazine April-1965 Methotrexate Topical gel (1%) Addl. Strength 25-11-2005 Methotrimeprazine (acid maleate) 5/25/100mg Tablet & 25mg/cc Ampoule January-1964 Methoxsalen USP-20mg Tablet 07.03.08 Methoxyflurane (Bottle of 125ml) October-1963 Methychlothiazide 2.5mg/5mg Tablet February-1961 Methyl Hydroxy Propyl Cellulose 0.3% Eye Drops 5-7-2000 Methyl Cobalamin 13-02.2002 Methyl cobalamine 500mcg+folic acid1.5mg+B5-5mg,+Zn.sulphate 25mg+Cr.Polynicotinate 31.10.07 200mcg+selenium- 65mcg+inositol-1.5mg + alpha lipoic acid – 100mg capsule Methyl cobalamine 500mcg+folic acid1.5mg+B5-5mg,+Zn.sulphate 25mg+Cr.Polynicotinate 31.10.07 200mcg+selenium-65mcg+inositol- 1.5mg + alpha lipoic acid –100mg capsule Methyl cobalamine 500mcg+folic acid1.5mg+B6-3mg,+Zn.sulphate 61.8mg+Ca.Pantothenate 29.11.07 10mg+ Niacinamide- 50mg +chrimium-50mcg capsule Methyl cobalamine 500mcg+folic acid1.5mg+B6-3mg,+Zn.sulphate 61.8mg+Ca.Pantothenate 29.11.07 10mg+ Niacinamide-50mg +chrimium- 50mcg capsule Methyl Dopa 250mg Tablet March-1963 Methyl Phenidate ER Tablet 10/20/30mg 10.07.2009 Methyl prednisolone aceponate- 1mg + salicylic acid-50mg ointment 19.11.07 Methyl Prednisolone Aceponate Cream (0.1%) 15-06-2006 Methyl prednisolone aceponate-1mg + salicylic acid-50mg ointment 19.11.07 Methyl valerate 100mg+ Quinine Anhydrous 15mg+ Camphor 10mg+ Oil of eucalyptus 10mg 06.06.1997 capsule Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) Tablet FDC of 16-09-2005 Methylcobalamin 500/750/1500mcg + Alpha Lipoic Acid 100/200 + Pyridoxine 1.0/1.5/3mg 26.09.2007 + Folic Acid 0.5/0.75/1.5mg Soft Gelatin Capsules Methylcobalamin (1500mcg E.R) + Pyridoxine (20mg) + Folic Acid (5mg) TabletFDC of 16-09-2005 Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) 31-07-2007. Soft Gelatin Capsule. Methylcobalamin (500mcg) + Alpha Lipoic Acid (100mg) + Pyridoxine (3mg) + Folic acid (1.5mg) 31-07-2007. Soft Gelatin Capsule. Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D- Panthenol 31.03.08 IP 50mg per 2 ml of injection Methylcobalamin 1000mcg + Pyridoxine Hcl IP 100mg + Nicotinamide IP 100mg + D-Panthenol IP 31.03.08 50mg per 2 ml of injection Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets 4.11.2009 Methylcobalamin 1500 mcg + Gabapentin SR 600 mg film coated tablets (additional strength) 4.11.2009 Methylcobalamin 1500 mcg orally disintegrating strips 10.03.2017 Methylcobalamin 1500mcg + Alpha Lipoic Acid 300mg Capsule 14.10.2008 Methylcobalamin 1500mcg + Calcium 200mg 14.01.09 + Calcitriol 0.25mcg + FolicAcid1.5mg + Pyridoxine 3mg Capsules

PHARMADOCX CONSULTANT 70 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Methylcobalamin 1500mcg (ER) + Pyridoxine 20mg IR + Folic Acid 5mg tablets 19.09.2005 Methylcobalamin 1500mcg + Alpha Lipoic Acid 100mg + Folic Acid 1.5mg + Selenium Dioxide 03.07.2008 163.6mg + Calcium Pantothenate 10mg + Vit B1 10mg + Vit B6 1.5mg + Vit E 25IU + Vit A 5000IU + Inositol 100mg + Chromium polynicotinate 200mcg soft gelatin capsules Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 50mg + Vit B6 3mg + 04.07.08 Biotin 5mg + Folic Acid 1.5mg capsule Methylcobalamin 1500mcg + Alpha lipoic acid 200mcg + Folic acid 1.5mg + Biotin 30mcg + 03.07.2008 Pyridoxine 3mg capsules Methylcobalamin 1500mcg + Alpha Lipoic Acid 200mg + Benfotiamine 50mg + Vit B6 3mg + 04.07.08 Biotin 5mg + Folic Acid 1.5mg capsule Methylcobalamin 1500mcg + Calcium 200mg 14.01.09 + Calcitriol 0.25mcg + Folic Acid1.5mg + Pyridoxine3mg Capsules Methylcobalamin 1500mcg + Pyridoxine 1.5mg 03.07.2008 + Folic acid 5mg capsules Methylcobalamin 1500mcg +Folic acid 0.7mg +Niacinamide 12mg injection 23-06-2010 Methylcobalamin 1500mcg +Folic acid 0.7mg 23-06-2010 +Niacinamide 12mg injection Methylcobalamin 1500mcg +Pyridoxine 100mg 23-06-2010 +Nicotinamide 100mg injection Methylcobalamin 1500mcg 23-06-2010 +Pyridoxine 100mg +Nicotinamide 100mg injection Methylcobalamin 150mg + Pyridoxine 12.5mg 05.09.2008 + Alpha Lipoic Acid + Inositol + Folic Acid Methylcobalamin 500mcg + Alpha lipoic acid 100mg + Beta Carotene 5.17mcg + Vit B1 2mg 04.07.2008 + Vit B2 2mg + Vit B6 1.5mg + Vit C 50mg + Vit D3 200IU + Vit E 10IU + Niacinamide 25mg + Folic Acid 50mg + Calcium Patothenate 5mg + Chromium Picolinate 2.5mg + Selenium Di oxide 1.4mg + Zinc Oxide 65mcg + Copper Sulphate 15mg + Manganese Sulphate 60mcg + Lutein 1mg tablet Methylcobalamin 500mcg + Alpha Lipoic Acid 100mg + Pyridoxine 1.5mg + Folic Acid 3mg Soft 31.07.2007 Gelatin Capsule Methylcobalamin 500mcg + Alpha Lipoic Acid 50mg + Folic Acid 1.5mg + Selenium Dioxide 31.01.2008 163.6mcg + Calcium Pantothenate 10mg + Vit B1 10mg + Vit B6 1.5mg + Vit E 25IU + Beta Carotene 20.66mg tablet Methylcobalamin 500mcg + Ascorbic acid 100mg + Niacinamide 50mg + Vit E 25mg + Calcium 30.01.2008 Pantothenate 12.5mg+ Vit B1 10mg + Riboflavin 10mg + Vit B6 3mg + Vit A 5000IU + Folic Acid 1mg + Zinc Oxide 15mg + Copper Gluconate 2.5mg + Manganese 1.4mg + Chromium 65mcg + Selenium 60mcg tablets Methylcobalamin 500mcg + Beta Carotene 20.66mg + Vit A 5000IU + Alpha Lipoic Acid 50mg + 01.03.2008 Folic Acid 1.5mg + Selenium 163.6mcg + Calcium Pantothenate 10mg + Vit B1 1.5mg + Vit B6 + Vit E 25IU tablets Methylcobalamin 500mcg + Calcium 250mg + Calcitriol 0.25mcg + Folic Acid 1.5mg + Pyridoxine 28.12.2007 3mg + Zinc 7.5mg Capsules Methylcobalamin 500mcg + Folic acid 1.5mg + B5 - 5gm + Zinc Sulphate 25mg + Chromium 31.10.2007 Polynicotinate 200mcg + selenium 65mcg + B6 1.5mg + inositol 100mg + Alpha lipoic acid 50mcg Capsules(Each inner capsule contains - Streptococcus Faccalis T-110 JPC 30 Million;Clostridium butyricum TO-A 2 Million;Bacillusmesentericus TO-A JPC 1 Million;Lactic acid bacillus 50 Million) Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium 11.01.11 Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 30 Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) Capsule

PHARMADOCX CONSULTANT 71 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Methylcobalamin 500mcg + Folic Acid IP 1.5mg + Zinc Sulphate IP 25mg + Chromium 11.01.11 Polynicotinate 200mcg + Selenium as Sodium Selenite USP 65 mcg + Inositol 100mg + Alpha Lipoic Acid 50mg + Streptococcus faecalis 3Millions (30 lakh) + Clostridium butyricum 2 Million (20 lakh) + Bacillus mesentericus 1 Million (10 lakh) + Lactic acid bacillus 50 Million (500lakh) Capsule Methylcobalamin 500mcg + L- Arginine 13.28mg + L- Histidine 3.71mg + L- Isoleucine 5.9mg + L- 14.10.2008 Leucine 18.3mg + L- Lysine 25mg + DL Methiononie 18.4mg + L- Phenylalanine 5mg + L- Threonine 4.2mg + L- Tryptophan 5mg + L- Valine 6.7mg + 5-Hydroxy Anthranilic acid 0.2mg + Vit A 2500IU + Cholecalciferol 200IU + Tocopherol Acetate 7.5IU + Vit B1 5mg + Riboflavin 1.5mg + Nicotinamide 40mg + Calcium Patothenate 30mcg + Vit b6 0.75mg + Vit C 4mg + Biotin 20.5mg + Folic Acid 7.43mg + Copper sulphate 1.4mg + Ferrous sulphate 0.1mg + Magnesium sulphate 10mcg + Potassium iodide15mg + Sodium selenite200mcg + Zinc sulphate + Chromium polynicotinate Methylcobalamin 500mcg + Pyridoxine 3mg + Folic acid 1.5mg + Eicosahexanoic acid 90mg + 28.12.2007 Docosahexanoic acid 60mg + Vit E 25 IU + Vit C 100mg + Zinc 15mg + Selenium 60mcg Capsule Methylcobalamin 500mcg + Vit A 5000IU + Vit E25IU + Ascorbic Acid 100mg + Vit B1 10mg + 01.03.2008 Riboflavin 10mg + Pyridoxine 3mg + Niacinamide 500mcg + Folic Acid 50mg + Calcium Pantothenate 1mg + Zinc Oxide 12.5mg + Cupric Oxide 15mg + Sodium Selenate 2.5mg + Manganese Chloride 60mg+ Manganese 1.4mg + Chromium 65mcg tablets Methylcobalamin 500mcg + Vit C 75mg + Vit B6 10mg + Folic Acid 5mg + Carbonyl Iron 100mg 28.03.2008 capsules Methylcobalamin 500mcg + VitA 5000IU + Vit D3 400IU + Vit E 25mg + Calcium Pantothenate 14.05.2008 50mg + L- Glutamic Acid 50mg +Vit B1 10mg + Riboflavin 10mg + Vit B6 3mg+ Niacinamide 50mg + Vit C 75mg+ Biotin 260mcg + Folic Acid 1mg + Zinc Sulphate 60mg + Chromium Picolinate 150mcg + Selenium 100mcg + Manganese Sulphate 200mcg + Magnesium Hydroxide 10mg + Copper Sulphate 200mcg Tablet Methylcobalamin 500mcg + VitA 5000IU + Vit E 25mg + Vit C 75mg + Vit D3 400IU + Folic 19.02.2008 Acid 1.5mg + Biotin 150mcg + Vit B1 5mg + Riboflavin 5mg + Vit B6 1.5mg + Niacinamide 50mg + Calcium Pantothenate 10mg + L- Glutamic acid 50mg + Chromium Picolinate 250mcg + Selenium 70mcg + Zinc Sulphate 55mg + Copper Sulphate 2mg + Manganese sulphate 5mg + Sodium Molybdate 25mcg + Manganesium Oxide 10mg sugar coated tablets Methylcobalamin 500mcg +beta carotine- 10.33mg+alpha lipoic acid 100mg+B6 1.5mg+B1 2mg & 18-10-2007. Chromium Polynicotinate soft gelatin capsule Methylcobalamin 500mcg+beta carotine-10.33mg+alpha lipoic acid 100mg+B6 1.5mg+B1 2mg & 18-10-2007. Cr.polynicotinate. Methylcobalamin 750mcg + Pregabalin75/150mg + Vitamin B61.5mg + Folic acid0.75mg + 03-05-2010 Benfothiamine7.5mg capsules Methylcobalamin 750mcg + Alpha Lipoic Acid 100mg + Folic Acid 300mcg capsules 30.01.2008 Methylcobalamin 750mcg + Pregabalin 75/150mg + Vitamin B 61.5mg + Folic acid 0.75mg + 05-03-2010 Benfothiamine7.5mg capsules Methylcobalamin orally disintegrating strips 1500mcg (add. Dosage form/ 17.12.14 indication) Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine 16-10-2007. (2mg) + Calcium Picolinate (200mg) tablet. Methylcobalamine (500mcg) + Alpha Lipoic acid (100mg) + Pyridoxine HCl (1.5mg) + Thiamine 16-10-2007. (2mg) + Calcium Picolinate (200mg) tablet. Methylcobalamine 500 mcg+folic acid 1.5mg+ alpha lipoic acid – 100mg +B6-3mg+Thiamine 29.11.07 10mg capsule Methylcobalamine 500mcg +folic acid1.5mg+ alpha lipoic acid –300mg +Benfothiamine- 13.11.07 50mg. Capsule Methylcobalamine 500mcg+folic acid 1.5mg+ alpha lipoic acid –100mg +B6-3mg+Thiamine 10mg 29.11.07 capsule Methylcobalamine 500mcg+folic acid1.5mg+ alpha lipoic acid – 300mg +Benfothiamine-50mg. 13.11.07 capsule Methylcobalamine 750mcg + Adenosylcobalamin 500mcg + Folic Acid 1.5mg + Elemental Iron 30.01.2008 100mg capsules

PHARMADOCX CONSULTANT 72 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg + B6 1.5mg + 30.01.08 Calcium pantothenate25mg + Nicotinamide 50mg + Folic acid0.75mg capsule Methylcobalamine 750mcg + Alphalipoic acid 100mg + Benfothiamine 7.5mg + B6 1.5mg + 30.01.08 Calcium pantothenate25mg + Nicotinamide 50mg + Folic acid0.75mg capsule 250mg + HCTZ 15mg Tablet Feb-69 Methylmercadone (Nifuratel) (200mg) Tablet & (250mg) Vaginal Tablet December-1967 Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w +CMC 1.74%w/w 07-06-2010 +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w. GEL Methylparaben 0.15%w/w +Propyl paraben 0.05%w/w+Glycerin 20%w/w +CMC 1.74%w/w 06-07-10 +Allantoin 0.5%w/w +Benzyl alcohol 0.5%w/w. HCl (18, 36, 54 mg) E.R. tablet 08-12-2004 Methylprednisolone March-1978 Methylprednisolone aceponate-1mg + Mupirocin-20mg. cream 21.11.07 Methylprednisolone aceponate-1mg + Mupirocin-20mg. Cream 21.11.07 Methylprednisolone Acetate 40mg/ml Vial November-1962 Methylprednisolone Acrponate topical solution 0.1% 04.04.07 Metoclopramide (as HCl) 200mg / 400mg per ml Intranasal Solution 09.09.09 Metoclopramide 5mg+Dimethyl polysiloxane 250 mg tablet Aug-85 Metoclopramide Hcl IP 15mg 13-4-1992 C.R Tablet Metoclopromide Monohydrochloride 10mg Tablet December-1976 Metoclopromide Monohydrochloride 10mg/2ml Injection December-1976 Metolazone 23.04.2003 Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg) 25.08.08 Metolazone + Spironolactone FC Tablets (2.5/5mg + 50mg) 25.08.08 Metolazone 2.5/5mg + Spironolactone 50mg/50mg FC Tablet 25.08.2008 Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets 28.05.08 Metolazone 2.5mg + Losartan Potassium 25mg/50mg tablets 28.05.08 Metolazone 2.5mg + Ramipril 2.5mg/5mg 28.05.08 Metolazone 2.5mg + Ramipril 2.5mg/5mg 28.05.08 Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg Tablet 19-07-10 Metoprolol S(-) 25/50mg (ER) + HCTZ 12.5mg/12.5mg (IR) Tablets 11.11.2005 Metoprolol S(-) (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mg 16.05.07 Metoprolol S(-)25mg/50mg (ER) + Atorvastatin (IR)10mg tablets 01-04-2010 Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg tablets 26.02.07 Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) 10.04.07 Metoprolol (As succinate) 25mg + Amlodipine (As besylate) 5mg (additional strength) tablet 10.04.07 Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet (For additional 20.02.07 indication) Metoprolol (As succinate) 50mg/25mg ER) + Amlodipine 5mg/2.5mg tablet (For additional 20.02.07 indication) Metoprolol (As succinate) ER 25mg/50mg + Ramipril 2.5mg/5mg 26.02.07 Metoprolol 25mg/50mg + Chlorthalidone 12.5/ 13.04.2009 12.5 mg film coated bilayered Tablet Metoprolol 25mg/50mg + Chlorthalidone 12.5mg Each film coated bilayred tablet contains: 13.04.2009 Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg Each film coated bilayred tablet 25.04.2009 contains: Metoprolol 25mg/50mg + Chlorthalidone 6.25 mg /12.5mg film coated bilayred tablet (additional 25.04.2009 strength) Metoprolol 50/50/25 mg + Atorvastatin 20/10/10 mg + Ramipril 10/5/2.5 mg capsules 1.07.2009 Metoprolol 50/50/25 1.07.2009 mg + Atorvastatin20/10/10 mg + Ramipril 10/5/2.5 mg capsules Metoprolol 50mg + HCTZ 12.5mg Tablet Jun-89 Metoprolol ER + Amlodipine tablets (Additional Indication) 16.07.08 Metoprolol ER + Amlodipine tablets (Additional Indication) 16.07.08 Metoprolol S(-) (As succinate) 25mg + S(-) Amlodipine (As besylate 2.5/5mg 16.05.07 Metoprolol S(-) 25mg/50mg (ER) + Atorvastatin (IR)10mg tablets 04-01-2010

PHARMADOCX CONSULTANT 73 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg 02-07-2006 Metoprolol succinate ER 25 mg+Telmisartan 40mg Tablet 20.12.11 Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg 30-11-06 Metoprolol succinate 25mg /50mg ER + HCTZ 12.5mg tablets 30-11-06 Metoprolol Succinate equiv. to Metoprolol Tartrate 50mg + Amlodipine (as besylate) 5mg 7-2-2006 Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 28.01.08 10mg tablets Metoprolol Succinate Equivalent to Metoprolol Tartrate [ER 25/50mg] + Atorvastatin (As calcium ) 28.01.08 10mg tablets Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg 16-07-10 Metoprolol succinate ER 25/50 mg+Telmisartan 20/40mg Tablet 16-07-10 Metoprolol succinate ER 25mg+50mg + Olmesartan 20/20mg 19-07-10 Metoprolol Succinate S(-) ER Eq. to S (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 07.10.10 75mg/75mg tablet Metoprolol Succinate S(-) S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) 15-04-2005

Metoprolol Succinate S(-) ER Eq. to S (-) Metoprolol tartarate 25mg/50mg + Clopidogrel (IR) 07.10.10 75mg/75mg tablet Metoprolol Succinate S(-) S.R. tablets (equivalent to S(-) Metoprolol Tartrate 12.5mg/25mg/50mg) 15-04-2005 Metoprolol tartarate 100 Oct-82 mg+Hydroclorothiazide 12.5 mg Metoprolol Tartrate March-1982 Metoprolol Tartrate (Bulk) September-1982 Metoprolol Tartrate 1mg/ml Injection August-1985 Metoprolol Tartrate 50mg/100mg Tablet May-1982 Metoprolol Tartrate ER Tablet 75mg 3.10.2009 (additional strength) Metoprolol tartrate tablets 50 mg (Addl. Indication) 14.01.09 Metrizamide October-1981 Metromidazile (as benzoate) 10mg+Benzocaine 200mg per gram topical gel 1.09.2003 Metronidazole 1% w/w (Skin Ointment) Gel 19-7-1993 Metronidazole 10mg + Benzocaine 200mg Gel 09.11.2003 Metronidazole 250mg Oral Tablet & 500mg Vaginal Tablet March-1961 Metronidazole Benzoate (eq. to Metronidazole) 200mg/5ml Suspension August-1976 Metronidazole Benzoate (eq. to of Metronidazole) 125mg/5ml Suspenion April-1976 Metronidazole CR tablet 600mg 21.02.08 Metronidazole IP 2mg/ml I.V Injection November-1978 Metronodazole 100mg + Furazolidone 30mg + Kaolin & Pectin per 5ml suspension Mar-79 Metronodazole 40mg + Furazolidone 30mg + Kaolin 1gm + Pectin 20mg per 5ml suspension Oct-77 Mexiletine Hcl 250mg/10ml Injection August-1985 Mexiletine Hcl 50mg/150mg Capsule August-1985 Hcl August-1985 10mg/20mg/30mg Tablet Micafungin ( as sodium) Powder for solution for infusion 50mg / vial 31.01.09 Micafungin sodium for injection 100mg/vial (Additional Strength) 2.05.2014 Micafungin sodium for Injection 10mg per 05-12-2011 vial/50mg per vial (Additional Indication) Miconazole Nitrate 20mg/gm Powder August-1975 Miconazole 1% Eye Drops/Ophthalmic Suspension/Ointment July-1989 Miconazole 2% Cream December-1974 Miconazole Nitrate 100mg Vaginal Pessary June-1977 Miconazole Nitrate 2% Solution March-1979 Miconazole Nitrate IP 2% w/w+ Fluocinolone Acetonide IP 0.01% w/w Cream 13.02.15 Miconazole Nitrate IP 2%w/w + Flucinolone Acetonide IP 0.01%w/w cream 30.04.15

PHARMADOCX CONSULTANT 74 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Micronised Purified Flavonoid 1000mg (MPFF). "Each film coated tablet contains 28.11.13 diosmin 900mg and flavonoids expressed as Hesperidine 100 mg of Micronised Purified Flavonoid fraction of Rutaceae 1000mg (MPFF)" Micronised Purified Flavonoid Fraction of Rutacea 1000 mg (MPFF) Each film coated tablet 28.11.13 contains ͞Diosmin 900mg and Flavonoids expressed as Hesperidine 100mg of Micronised Purified Flavonoid Fraction of Rutaceae 1000mg (MPFF) (Additional strength) Midazolam (as maleate) 7.5mg/15mg tablet 10-5-2006 Midazolam BP 1mg/ml per vial (5ml/10ml) Injection Midazolam 5mg/ml ampoule Prefilled 15-4-1997 Syringe Midazolam Hcl Syrup 2mg/ml 18.12.2009 Midazolam Maleate Bulk 05-07-2005 Hydrochloride 2.5 mg Tablet 02.09.2016 Mifepristone 13.02.2002 Mifepristone + Misoprostol (1 tab of mifepristone 200mg and 4 tab of misoprostol 200mcg) 16.12.08 Combipack Mifepristone + Misoprostol (1 tab of mifepristone 16.12.08 200mg and 4 tab of misoprostol 200mcg) Combipack Miglitol (50mg) + Metformin HCl SR (500mg) tablet. 31-10-2007. Miglitol (50mg) + Metformin HCl SR (500mg) tablet. 31-10-2007. Miglitol 25 mg + Metformin 500mg tablets 16-03-2010 Miglitol 25 mg + Metformin 500mg tablets 16-03-2010 Miglitol Tablet 25 mg/50 mg/100 mg 18-08-2004 Milnacipran 100mg (additional Strength) 16.7.2009 Milnacipran 25/50mg Caps (Addl. Indication) 15.04.2009 Milnacipran Hcl 12.5mg (Addl. Strength) 06-02-2010 Milnacipran Hcl. 25mg/50mg equivalent to Milnacipran free base 21.77 or 43.55 mg. tablet. 22.05.08 Milrinone (as Lactate) 1mg/ml solution Injection 17-5-1999 Miltefosin Capsule 10mg/50mg (Additional Indication) 16.04.08 Miltefosine 15.03.2002 Minocycline 100mg Tablet/capsule May-1988 Minocycline 50mg Oral Suspension May-1988 Minocycline Hydrochloride Extended Release Tablets 45mg/65mg 29.08.2016 (Additional Strength) Minoxidil 20mg/ml Topical Lotion May-1988 Minoxidil IP 5 %+ Finasteride IP 0.1% lipid Solution for topical application Each ml contains 07.02.14 Prolonged Release Tablet 25 mg /50 mg 12.07.2017 Mirabegron Prolonged Release Tablet 25 mg /50 mg & Bulk 12.07.2017 14.02.2001 Misoprostol 21.06.2001 Misoprostol 50Mcg tablet (Additional Strength) 26.08.08 Misoprostol tablet 25mcg/100mcg/200mcg (additional strength indication 8-12-2006 Misoprostol Tablet 600mcg 09.01.09 Mitomycin-C 2mg/Vial December-1972 Mitoxantrone Hcl 2mg/ml Injection March-1989 Mixture of sodium Salt + Methyl glucamine salt of 35 diacetamido- 2,4,6-triodobenzoic acid May-75 Mizolastine 15.03.2002 MMR Vaccine 26-3-1999 MMR Vaccine 29-3-2000 Moclobemide 150mg/300mg Film Coated Tablet 28-7-2000 Modafinil 15-12-2003 Mometasone 0.1 % + Fusidic acid 2% cream/ointment 25.04.09 Mometasone 0.1 % 25.04.09 + Fusidic acid 2% cream/ointment Mometasone Furoate 0.1% + Salicylic Acid 5 % ointment Each gm of ointment contains 24.12.02 Mometasone Furoate 0.1% Cream/Ointment October-1990

PHARMADOCX CONSULTANT 75 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Mometasone furoate 0.1% w/w+Terbinafine Hcl 1% w/w Cream 16.01.2002 Mometasone Furoate IP 1 mg + Salicylic Acid IP 50 mg ointment (additional indication) Each 19.02.14 gram contains Mometasone furoate nasal spray 50 mcg/actuation (Additional Indication) 21.05.2014 MometasoneFuroateMonohydr ateequivalent to MometasoneFuroate aqueous Nasal Spray 30.04.2015* 50mcg/actuation (Additional Indication) Monensin Sodium 100gm/200gm per kg Premix (For Veterinary) September-1985 Mono ammonium glycyrrhizinate 4mg (as Glycyrrhizin) + Amino acetic acid 40mg + L- Cyptein 14.12.1995 HCl 2mg per 2 ml Inj. Mono basic Sodium Phosphate Monohydrate 276mg+Dibasic sodium Phosphate Heptahydrate 31.08.2000 268mg per ml injection Monocomponent Insulin Lispro 40 Iu/ml (rDNA origin) per 10ml vial Injection 1-12-1997 Monteleukast Sodium Tablet 10mg; Monteleukast Sodium 4/5mg Chewable Tablet; Monteleukast 12-06-2010 Sodium Oral granule(Additional Indication) Montelucast + Desloratidine(10mg + 5mg) FC Tablets 10.11.08 Montelucast + Desloratidine(10mg + 5mg) FC 10.11.08 Tablets Montelucast 10mg + Levocetirizine 5mg film coated tablets 31.01.08 Montelucast 10mg + Levocetirizine 5mg film coated tablets 31.01.08 Montelucast 4 mg+ Levocetrizine 2.5 mg tablet 03.03.2009 Montelucast 4 19.03.09 mg+ Levocetrizine 2.5 mg tablet Montelukast 10mg + Fexofenadine 120mg Chewable Tablets (Additional dosage form) 07.07.2011 Montelukast Granules (4mg/pack) 17-05-2005 Montelukast Orally Disintegrating Strips 4mg/5mg/10mg (additional Dosage form) 29.05.15 Montelukast Sod. Eq. to Montelukast 10mg/10mg+ Bambuterol HCl BP 10mg/20mg film coated 10.04.2003 tablet Montelukast Sod. Eq. to Montelukast 5mg/5mg+ Bambuterol HCl BP 5mg/10mg film coated tablet 04.06.2003 Montelukast Sodium 13.02.2002 Montelukast Sodium 10 mg Tablet, Montelukast Sodium 4/5 mg Chewable Tablet and Montelukast 11.09.10 Sodium Oral Granules (Additional Indication). Montelukast sodium chewable tablet 4mg/5mg and Montelukast sodium film coated tablet 10mg. 26.02.2002 Montelukast Sodium IP eq.to Montelukast 10mg +Olopatadine Hcl 5mg Tablets 16.12.11 Montelukast Sodium IP eq.to Montelukast 16.12.11 10mg +Olopatadine Hcl 5mg Tablets Montelukast Suspension 5mg/5ml 16.09.08 Morphazinamide Hcl. 0.5gm Tablet July-1967 Morphine Sulphate 60mg Film Coated CR Tablet 18-7-1994 Mosapride 12.03.2001 Mosapride Citrate dihydrate eq. to Mosapride cotrate-5mg+MPS (Methyl Polysiloxane 125mg 30.01.2002 chewable tablets Moxidectin 1% w/v Injection (For Veterinary) 16-1-1997 Moxifloxacin 26.06.2001 Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops 24-11-2005 Moxifloxacin (0.5%) + Dexamethasone Phosphate (0.1%) Eye drops 24-11-2005 Moxifloxacin Eye drops (0.5%) 26-08-2004 Moxifloxacin Eye Ointment (5mg/gm) 6-2-2006 Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic Solution. 11-07-2007. Moxifloxacin HCL (0.5%) + Ketorolac Tromethamine 0.5% Ophthalmic Solution. 11-07-2007. Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg) per ml. (eye drops) 16-10-2007. Moxifloxacin HCl (5mg) + Prednisolone Acetate (10mg)per ml. (eye drops) 16-10-2007. Moxifloxacin HCl BP 0.5% w/v + Bromfenac Sodium 0.09% w/v Eye drop 05.01.11 Moxifloxacin HCl BP 0.5% w/v + 05.01.11 Bromfenac Sodium 0.09% w/v Eye drop

PHARMADOCX CONSULTANT 76 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Moxifloxacin HCl Eq. to Moxifloxacin base 31.10.2008 5mg Dexamethasone Sodium Phosphate Eq. to Dexamethasone Phosphate 1mg Ophthalmic solution (Additional indication) Each ml contains: Moxifloxacin HCl Eq. to Moxifloxacin base 31.10.2008 5mg Dexamethasone Sodium Phosphate Eq. to Dexamethasone Phosphate 1mg Ophthalmic solution (Additional indication) Each ml contains: Moxonidine tablet 0.2mg/0.3mg/0.4mg 27.02.07 Mucotrol Concentrated Oral Gel Wafer. 07.03.12 Multi Organ Preservative Solution Component A: (1000ml/2000ml/4000ml) Each 100ml contains 31.01.2001 : Glucose anhydrous 3.57gms component B: (20ml/40ml/80ml) Supplementary Electrolyte Solution : Potassium. Dihydrogen Phosphate 10.76gm+ Pot. Mono Hydrogen Phosphate 37.74gm + KCL-5.7 gm +Sodium Bicarbonate IP 4.3 g + Hydrochloric acid ( to adjust pH)

Mupirocin (2%) + Methylprednisolone Aceponate (0.1%) Cream. 31-10-2007. Mupirocin (2%) + Methylprednisolone Aceponate (0.1%) Cream. 31-10-2007. Mupirocin 2% w/w Topical Ointment September-1991 Mycophenolate Mofetil 250mg/500mg Capsule/Tablet 7-2-1999 Mycophenolate Mofetil Capsule 250mg, 500mg & Oral suspension 200mg/ml (Additional 23.01.08 Indication) Mycophenolate mofetil Capsules 250mg, Tablets 500mg, Oral suspension 200mg/ml (addl. 23.01.09 Indication) Mycophenolate Mofetil Tablets 750mg Additional Strength 31.03.09 Mycophenolate Sodium Enteric coated tablet 540 mg (Additional Strength) 29.10.2009 N - butanol 0.52gm + Citric Acid 0.0025gm + Physiological sodium chloride add to 5ml per 5 ml Nov-72 Nabivolol Hcl eq. Nabivolol 5 mg + HCTZ 12.5mg Tablets 23.12.2004 Nabumetone 500mg/750mg Film Coated Tablet 17-5-1999 N-Acetyl-Sulphamethoxy Pyridiazine (Pediatric suspension) April-1961 NaCl 0.52g + KCl 0.3g + Sod. Citrate 0.58g + Dextrose Anh. 2.7g per 200ml ORS in Liquid form 23.07.2007 NaCl-0.125gm+KCl 0.150gm+NaHCO3- 22.04.1996 0.250gm+Citric acid (anhydrous)-0.577gm+ Dextrose (anhydrous) 2.650gm ORS Tablets Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream 6-6-2006 Nadifloxacin (1%) + Miconazole Nitrate (2%) + Mometasone Furoate (0.1%) Cream 06-06-2006 Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream 17-08-06 Nadifloxacin (10mg/gm) + Mometasone Furoate (1mg/gm) cream 17-08-06 Nadifloxacin 10mg + Miconazole 20mg cream 09.3.2003 Nadifloxacin 10mg+Clobetasol propionate 500mcg each gram gel & cream 06.10.2003 Nadifloxacin Cream 28.03.2002 Nadifloxacin Gel 1% 10-5-2006 40mg/80mg Tablet September-1985 Nadolol tablet USP 20/40/80 mg 20-08-10 Nafarelin Acetate 2mg/1ml Nasal Spray 17-3-1999 Tablets 25/50/75mg 30-07-10 Nalbuphine injection 10mg/20mg per ml. 07.02.07 Nalidix Acid 500mg Tablet April-1969 Naloxone Hcl 0.02mg/0.4mg/1.0mg per ml (i.v/i.m/s.c) Injection 28-7-1992 Naltrexone Hcl 50mg Uncoated Tablet 11-10-1996 Nandrolone Decanoate Injection May-1962 Nanocrystalline Silver Gel 0.002% 04.01.08 Naproxen 10% w/w Topical Gel 31-8-1994 Naproxen 250mg Tablet January-1979 Naproxen 375mg Tablet February-1990 Naproxen 750mg C.R Tablet 26-6-1995 Naproxen Suspension 125mg/5ml 28.04.08

PHARMADOCX CONSULTANT 77 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Naratriptan (as HCl) Tablets 1/ 2.5mg 18.7.2009 Natamycin 2% Cream September-1979 Natamycin 25mg Vaginal Tablet October-1979 Nateglinide 01.05.2002 Nateglinide 60/120 mg + Metformin500mg/500mg SR Tablet 01.8.2004 Natiglinide 60mg/120mg + Metformin HCl 500mg/500mg (SR) tablet 08.01.2004 N-butyl Cyanoacrylate 0.5ml Bioadhesive (Liquid adhesive) 6-6-1996 Nealbarbitone 60mg/200mg Tablet February-1962 Nebivolol (5 mg) + S(-) Amlodipine (2.5 mg ) tablet FDC of 14-09-2004 Nebivolol (as HCl) 5mg + Valsartan 80mg 17-01-2006 Nebivolol (as HCl) 5mg + Valsartan 80mg 17-01-2006 Nebivolol 5mg + Amlodipine 10mg FC Tablet 06.09.2006 Nebivolol 5mg + HCTZ 12.5mg tablets 23.12.2004 Nebivolol HCl 12.07.2002 Nebivolol HCl (5mg) + Hydrochlorothiazide (12.5mg) tablet FDC of 22-12-2004 Nefopam Hydrochloride 30mg Tablet. April-1991 Nefopam Hydrochloride 20mg/ml Injection. Nelfinavir 625mg tablet (addl.strength) 20-05-2005 Nelfinavir Mesylate 02.07.2001 Neomycin + Bacitracin+ Polymix B Sulphate ointment Nov-77 Neomycin Sulphate IP 5 mg (3000 IU) + Bacitracin Zinc IP 500 IU (veterinary product) Each 07.08.14 gram of ointment contains- Neomycin Sulohate 910mg + Polymyxin B Sulphate 300000 units + Zinc bacitracin 25000units + Mar-77 Propellent to maba 210gm aerosol pouch of 210gm Neotame 22-04-2004 Nepafenac Opthalmic suspension (1mg/ml) 31.03.08 Netilmicin Sulphate 10mg/25mg/50mg/100mg/ml Injection August-1985 Neutral Insulin & Insulin Zinc Suspension (Human Insulin) Injection September-1987 Neutral insulin and Insulin Zinc suspension Sep-87 Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg film coated tablets 24-05-2006 Nevibolol (as HCl) 5mg + Amlodipine (as besylate) 5mg/10mg 24-05-2006 Nevirapine 200mg Tablet Nevirapine 50mg/5ml Suspension 6-3-2000 Nevirapine Extented release tablet 400mg (Additional Strength) 01.07.2014 Nevirapine tablet 50 mg for oral suspension mg 18.7.2009 Niacin 1000mg ER + Laropiprant 20mg Tablet 31.03.2010 Nicardipine Hcl 20mg/30mg Capsule 27-10-1993 Nicardipine Hcl 40mg/30mg (as pellets) Retard Capsule 9-10-1996 Nicardipine Hcl. Injection 2.5mg/ml 07.04.08 5mg/30mg Dragee/Sugar Coated Tablet October-1985 Niclosamide February-1965 Nicorandil 2mg/12mg/48mg 26-3-1999 i.v Injection Nicorandil 5mg/10mg/20mg Uncoated Tablet 10-1-1997 Nicorandil E.R Tablet (10mg/20mg) 24-04-2006 Nicotinamide Hydrochloride September-1962 Nicotine (as Polacrilex) Lozenges 2mg & 4mg 18.02.09 Nicotine Polacrilex Gum 2mg & 4mg (Addl. Indication) 03.02.09 Nicotine Transdermal Therapeutic System 17-5-1995 Nicotinic Acid and Laropiprant Modified Release Tablets: Nicotinic Acid. 1000 26-03-2010 mg Laropiprant 20 mg Nicoumalone Tablets 0.5mg/5mg/6mg 18.1.13 Nifedipine 20mg Sustained Release Tablet November-1989 Nifedipine 0.3% + Lidocaine1.5% cream 26.02.09 Nifedipine 0.3% + Lidocaine1.5% cream 26.02.09 Nifedipine SR Tablets 10mg/20mg 24.03.08

PHARMADOCX CONSULTANT 78 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Nifedipine USP 5mg/10mg Capsule December-1984 Niflumic acid February-1975 Niflumic Acid 250mg Capsule April-1975 Niflumic Acid 250mg Capsule May-1979 Nilotinib Capsules 150 mg. 29-09-10 Nilotinib Capsules 200mg 10-07-10 Nilutamide Tablets October-1991 Nimesulide 1% + Methyl Salicylate 5%. Aerosol 16-09-2005 Nimesulide 1% + Methyl Salicylate 5%. 16-09-2005 Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution 17.11.2009 Nimesulide 1.0% w/w + Ethanol 31% w/w topical solution 17.11.2009 Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets 28.03.08 Nimesulide 100mg ER + Levocetirizine HCl 5mg Tablets 28.03.08 Nimesulide 100mg Tablet Nimesulide 50mg/5ml Suspension 13-1-1995 Nimesulide Transdermal 1% Gel Nimesulide 50mg/100mg Suppository Nimesulide 50mg/100mg/200mg Suppository 17-5-1999 Nimesulide ER 200mg ( Additional Indication) 16.05.2009 Nimesulide Injection (100 mg/ml) (Veterinary) 08-10-2004 Nimesulide Injection 75mg/ml. 28-06-2004 Nimesulide100mg + Paracetamol 500mg Tablets Approved for more than 4 years Nimodipine 30mg Tablet Nimodipine 10mg/50ml Injection iiNimodipine 30mg Soft Gelatin 31-8-1992 Capsule Nimorazole 250mg Tablet October-1977 Nimustine Hydrochloride 25mg/50mg per vial Injection August-1985 Nintedanib Soft Gelatin Capsule 100/150mg (Nintedanib ethanesulfonate) 01.04.16 Nitazoxanide 17-03-2004 Nitazoxanide (500mg) + Ofloxacin (200mg) Tablet 30-06-2005 Nitazoxanide (500mg) + Ofloxacin (200mg) Tablet 30-06-2005 Nitrazepam June-1973 Nitrazepam 5mg Tablet September-1973 Nitrendipine 10mg/20mg Tablet May-1991 Nitrendipine 10mg/20mg+Atenolol 30mg/30mg tablets 19.09.1995 Nitrofurantoin BP 100mcg/200mcg Sensitive Disc March-1974 Nitrofurantoin dispersible tablets 50 mg (add. Strength/ dosage form) 15.12.14 Nitrofurantoin SR Tab. 100mg 26.09.08 Nitrofurazane 0.06gm + urea 6.21gm bolus Aug-73 Nitroglycerin 25mg/50mg Patch 3-6-1993 Nitroglycerin Injection June-1986 Nitroglycerin Oitnment January-1982 Nitroglycerine 2.6mg Sustained Release Tablet March-1975 Nitroglycerine-10/20/40mg+Dextrose Hydrous 5gm Injection 02.04.2002 Nitroscanate 100mg/500mg Tablet (For Veterinary) 19-2-1996 Nitroxazepine Hydrochloride 25mg Tablet October-1973 Nitroxazepine Hydrochloride 25mg/2ml Injection September-1973 N-N-decamethylene-N-N- decamethylene-bis-amino quinaldine (Salvizol), 0.25mg Loz. & 0.4% May-1962 Oint. Nonoxynol 2% w/v+Chlorometoxylenol 0.5% w/v 26.07.1995 Norethindrone (7 pills of 0.5mg )& 35 mcg ethinylestradiol Tablets, 7 pills of 0.75mg Jan-88 Norethindrone & 35 mcg ethinylestradiol Tablets and 7 pills of 1mg Norethindrone & 35 mcg ethinylestradiol Tablets Norethindrone acetate 5mg Tablet June-1961 Norethindrone-1mg + Mestranol-0.05mg Tablet Septembet-1970 Norethisterane acetate + ethinyl estradiol May-67 Norethisterone B.P 0.35mg Tablet May-1977

PHARMADOCX CONSULTANT 79 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Norethisterone Enanthate Injection April-1986 Norethisterone 1mg + Ethinyl estradiol 30mcg Tablet Jun-77 Norethisterone 2mg and Mestranol 0.1mg May-67 Norethisterone acetate Tablets of + Ethinyl oestradiol Nov-62 Norethynodrel Tablets of and Ethinyl Estradiol 3-methyl ether Dec-62 Norfloxacin 0.3% Eye Drops/Ear Drops/Eye Ointment February-1990 Norfloxacin 200mg/400mg/800mg Tablet November-1987 & 100mg ODT(July-93) Norfloxacin USP 100mg per gm Powder 10% (For Veterinary) 12-3-1997 Norgestimate 180µgm/215µgm/250µgm + Ethinyl oestradiol 35µgm/35µgm/35µgm Tablets 29.06.1993 (Triphasic oral contraceptive tablets) Norgestrel + Ethinyloestradiol Tablet Aug-68 Norlestrin Tablet April-1965 Northynodrel 2.5mg + Mestranol 0.1mg Jun-67 Nova-T August-1987 N-Phenylethyl Anthranilic Acid 300mg Capsule April-1978 Octinoxate 7.5% + Avobenzone 2% + 19.03.09 Oxybenzone 3% + Octocrylene 3% + Zinc Oxide 2% lotion Octinoxate 7.5% + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotion 23.02.09 Octinoxate 7.5% + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3% + Zinc Oxide 2% Lotion 19.03.2009 Octinoxate 7.5% 19.03.09 + Avobenzone 2% + Oxybenzone 3% + Octocrylene 3%+ Zinc Oxide 2% lotion Octinoxate 7.5% 23.02.09 + Avobenzone 3% + Oxybenzone 3% + Titanium dioxide 2% lotion Octinoxate 7.5%+ Avobenzone 2% + Oxybenzone 3% + Zinc Oxide 2% Lotion 23.02.2009 Octreotide Injection 30-6-1994 Oestradiol Phenyl Propionate 1ml Ampoule January-1964 O-Ethoxybenzamide 200mg/500mg Dragees February-1961 Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion 17.08.2009 Ofloxacin (200mg) + Ornidazole (500mg) Tablets 20-01-2005 Ofloxacin (200mg) + Ornidazole (500mg) 20-01-2005 Ofloxacin 100mg/200mg/400mg Tablet February-1990 Ofloxacin 100mg/50ml & 200mg/100ml vial Infusion May-1991 Ofloxacin 2mg + Ornidazole 5 mg per ml Infusion 17.08.2009 Ofloxacin 3mg/ml Eye Drops December-1991 5mg/10mg+ Fluoxetine HCl eq. to Fluoxetine 20mg/20mg tablet 18.02.2003 Olanzapine 5mg/7.5mg/10mg/2.5mg Tablet 27-1-2000 Olanzapine pamoate Prolonged release powder for suspension for I.M injection (combi pack) 14.10.14 Each combipack contains a. Vial of Olanzapine pamoate Prolonged release powder for suspension. Each vial contains: Olanzapine pamoate monohydrate eq to Olanzapine..... 210mg/300mg/405mg.After reconstituton each mL of suspension contains 150mg. b. Vial of vehicle: 3mL clear, colourless to slight yellow solution contains: Manitol IP.... 5.070%w/v Sodium carboxymethyl cellulose IP.... 0.770% w/v Polysorbate 80 IP..... 0.025%w/v HCL IP....q.s. NAOH IP....q.s Water for injection....q.s. to 100% Olanzapine powder For oral suspensian (10mg/5ml) 11-8-2006 Olmesartan 40mg + Amlodipine 5mg Tablet (Additional Strength) 08-09-2010 Olmesartan (20/40mg )+ Atorvastatin 5/10/20mg film coated tablets 27.10.2009 Olmesartan (20/40mg)+ Atorvastatin 5/10/20mg film coated tablets 27.10.2009 Olmesartan (as Medoxomil) 10mg (addl. Strength) 18-05-2006 Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength) 15.09.08

PHARMADOCX CONSULTANT 80 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Olmesartan + Ramipril (40mg + 5mg) tablets (Additional Strength) 15.09.08 Olmesartan 40mg + Amlodipine 5mg (Additional Strength) 09-08-10 Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength) 28-06-2006 Olmesartan 40mg + HCTZ 25mg tablet (addl. Strength) 28.05.2006 Olmesartan 40mg + Ramipril 5mg Tablet 19.08.2008 Olmesartan medoximil-20mg + Ramipril-5mg. tablet 12.6.07 Olmesartan medoximil-20mg + Ramipril-5mg. Tablet 12.6.07 Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet. 15-10-2007. Olmesartan Medoxomil (20mg) + Amlodipine Besylate (5mg) Tablet. 15-10-2007. Olmesartan Medoxomil (20mg/40mg/ 40mg) + HCTZ(12.5mg/12.5mg/25mg) FDC of 02-12-2005 Olmesartan Medoxomil (20mg/40mg/40mg) + HCTZ(12.5mg/12.5mg/25mg) FDC of 12-02-2005 Olmesartan Medoxomil (5mg/20mg/40mg) Tablet 21-07-2005 Olopatadime Ophthalmic solution (0.2%) (additional Strength) 24.04.07 Olopatadine Hcl Nasal Spray 0.6% w/w (Additional Indication) 10-02-2010 Olopatadine Hcl. Tablet 2.5mg/5mg 26.02.07 Olopatadine Nasal Spray (0.6%) 05.08.08 Olopatadine Ophthalmic solution( 0.1%) 8-6-2006 Olopatadine5mg + Ambroxol30mg tablets 05-03-2010 Olopatadine5mg + Ambroxol30mg tablets 03-05-2010 Omega-3 acid ethyl esters (90%) 1000mg comprising (Eicosapentaenoic acid (EPA) ethyl ester 16.03.2011 460mg + Docosahexaenoic acid (DHA) ethyl ester 380mg) capsules (Additional Strength)

Omeprazole (20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength). 15-10-2007. Omeprazole (20mg) Enteric coated + Domperidone (30mg) (S.R.) capsule 03-10-2005 Omeprazole (20mg) Enteric coated + Domperidone (30mg) (S.R.) capsule 10-03-2005 Omeprazole (20mg/40mg)+Sod. Bicarbonate- 600mg+ Mg.Hydroxide-700mg .chew tab. 08-01-2007 Omeprazole (20mg/40mg)+Sod. Bicarbonate-600mg+ Mg.Hydroxide-700mg .chew tab. 1-8-2007 Omeprazole (E.coated) 40mg + Sodium Bicarbonate 1100mg capsule. 18-6-2007. Omeprazole (E.coated) 40mg + Sodium Bicarbonate 1100mg capsule. 18-6-2007. Omeprazole 10mg/20mg Enteric Coated Granules Capsule April-1991 Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet 19.03.09 Omeprazole 20/40mg + Sodium Bicarbonate 600mg+ Magnesium Hydroxide 700mg sachet 19.03.09 Omeprazole 20mg (EC) + Domperidone 10mg Capsule 07.05.2005 Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules 15.06.07 Omeprazole 20mg/40mg + Sodium Bicarbonate 1100mg capsules 15.06.07 Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension 12.03.08 Omeprazole 20mg/40mg + Sodium bicarbonate 1680mg per sachet powder for oral suspension 12.03.08 Omeprazole Magnesium 10mg/20mg Enteric Coated Tablet 17-9-1999 Omeprazole Magnesium Delayed Release Granules for oral Suspension 10mg 16.02.2016 Omeprazole Powder for suspension (20mg/Sachet) 30-11-2005 Omeprazole Sodium 40mg per vial Injection 6-9-1994 Omeprazole(20mg) + Sodium bicarbonate (1100mg) tablet (addl. strength). 15-10-2007. Ondansetron Fast Dissolving Strips 4mg/8mg 22-11-2011 (New dosage form) Ondansetron Hcl Dihydrate 4mg/8mg Film Coated Tablet Ondansetron Hcl Dihydrate 4mg/2ml 12-2-1994 ampoule Injection Ondansetron Hcl Dihydrate 8mg/4ml ampoule Injection Ondansetron Hydrochloride Mouth Melting Strips 4mg 29.3.12 Ondansetron Hydrochloride Oral Spray 2mg (Each spray delivers ondansetron-2mg) 8.11.12 Ondansetron orally disintegrating tablet (4mg/8mg) (additional dosage form) 28-09-2007. Ondansetron Rapid Film Oral Strip 4/8 mg 16.11.10 Opipramol dihydrochloride Tablet 50mg/100mg. 13.11.10. Oral Polio Vaccine 6-5-1992 Oral Typhoid Vaccine Caps 17-5-1993 Sulphate 10mg Syrup December-1969 Orciprenaline Sulphate Tablet, Injection & Solution inhalation. April-1965 Orlistat (120 mg) Capsule 27-10-2004 Ornidazole 500mg Tablet Ornidazole 5mg/ml Infusion (100ml infusion bottle) 13-1-1997

PHARMADOCX CONSULTANT 81 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w Ointment 03.01.12 Ornidazole IP 1 % w/w + Povidone Iodine IP (0.5% w/w available Iodine) 5% w/w Ointment 03.01.12 Orphenadrine citrate 35mg + Paracetamol 450mg tablet Nov-77 Orphenedrine Citrate 60mg/2ml Ampoule November-1977 Orthoclone Sterile (OKT3) October-1990 Oseltamivir (as phosphate) Capsule (75mg) & oral suspension (12mg/ml) 25-10-2005 Oseltamivir 30mg & 45mg Capsules (Additional Strength) 28.01.08 Oseltamivir formulation (additional indication) 24-04-2006 Oseltamivir Phosphate (Additional indication) 19-06-2010 Osimertinib 40 mg/80 mg Film coated Tablets (Osimertinib Mesylate) 29.05.2017 Otilonium Bromide 40mg Tablet 15-12-2000 Oxaceprol Bulk 15.03.2011 Oxaceprol capsule 200mg 15.03.2011 Oxacillin Sodium 250mg Capsule April-1963 Oxaliplatin 50mg/100mg per vial Freeze Dried Powder for 26-10-1998 i.v Injection Oxandrolone Tablet (2.5/10mg) 4-8-2006 Oxaprozine Tablet (600mg) 30-10-2007. Oxazepam 10mg Tablet April-1966 Oxazepam 10mg Tablet March-1967 Oxazepam 30mg Tablet May-1969 Oxcarbazepine 30.10.2001 Oxcarbazepine 150/300/600mg Tablet (Addl. Indication 13.08.2009 Oxcarbazepine S.R 450mg/900mg (addl. Strength). 19-05-2006 Oxcarbazepine S.R. (150mg/300mg/600mg) Tablet 08-09-2005 Oxcarbazepine Tablets (Additional Indication)150/300/600 mg 26.11.2009 Oxethazine Hcl. (5ml) Gel June-1967 Oxibendazole 1.33% w/w Premix (For Veterinary) May-1976 Oxiconazole Nitrate 1% w/v Cream & Lotion 17-1-2000 Oxolinic acid September-1974 Hydrochloride June-1973 Oxybutynin Chloride 2.5mg/5mg Uncoated Tablet Oxybutynin Chloride 2.5mg/5ml Syrup 3-9-1998 Oxybutynin Gel 100 mg 04.11.10 Oxybutynine E.R. tablets 05-05-2004 Oxyclozanide (For Veterinary) November-1972 April-1973 Oxyfedrine (8mg) Tablet, (10mg) Solution, (2mg/ml) Injection July-1973 Oxyfedrine 24mg Tablet April-1979 Oxymetazoline November-1967 Oxymetazoline Hydrochloride 0.25% (Paediatric) October-1978 Oxymetazoline Hydrochloride Nasal Spray50mcg/0.05%w/w 19.08.2009 Oxymetholone 5mg Tablet March-1961 Oxyphenbutazone 0.1gm Tablet November-1961 Oxyphencyclamine Hcl. 10mg Tablet May-1961 Oxytetracycline HCL-500mg+Furazolidone- 500mg+Clioquinol-500mg per 100 gm syringe 5.07.1993 Oxytetracycline 250mg Ampoule June-1967 Oxytetracycline Dihydrate 200mg/ml Injection (For Veterinary) May-1990 Ozagrel Hcl. Tablets 100mg/200mg 28.01.08 Ozothine 60mg Tablet December-1987 Ozothine 60mg/5ml Syrup December-1987 Paclitaxel (protein bound particle) for injectable suspension (paclitaxel (100mg) + Albumin Human 11-10-2007. 900mg per 20ml injection Paclitaxel (protein bound particle) for injectable suspension (paclitaxel (100mg) + Albumin Human 11-10-2007. 900mg per 20ml. Paclitaxel 30mg/5ml single dose vial Injection 25-8-1994 Paclitaxel inj.30/100/300mg vial (Addl. Indication) 08.11.08

PHARMADOCX CONSULTANT 82 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Paclitaxel Injection 30mg/100 mg/300 24.02.11 mg (additional Indication) Paclitaxel Injection Concentrate for Nanodispersion 100mg and 300mg 22.01.14 (Additional Dosage Form) Paclitaxel Lipid Suspension for Injection 30mg/vial and 60mg/vial 02.08.2016 (Additional Dosage Form) Paclitaxel nanoparticle Inj. (20mg/ml) 23-08-06 Paclitaxel Nanoparticle injection 20.02.2009 Each vial contains: Paclitaxel USP 100mg Human Albumin IP 900 mg Paclitaxel Nanoparticle injection 20.02.2009 Each vial contains: Paclitaxel USP 100mg Human Albumin IP 900 mg Paclitaxel Nanoparticle Solution for Injection 20mg/ml (Additional indication) 22.01.08 Paclitaxel suspension for injection Conc. For nanodispersion 100/300mg (add. 18.12.14 Indication) Palbociclib Capsules 75mg/100mg/125 mg 11.08.2016 ER tablet 12 mg (Additional Strength) 14.11.2009 Paliperidone ER Tablet 3mg / 6mg / 9mg 26.09.08 Paliperidone ER Tablets 1.5mg 04.03.09 Palonesetron Injection 0.25mg/5ml (Additional Indication) 16.05.2009 Palonosetron Hcl 0.075mg IV Inj (Addl. Strength) 25.04.2009 Palonosetron Melt in Mouth Tablets 0.5mg 19.3.13 Pamabrom 50mg Tablet April-1962 P-Aminomethyl Benzoic Acid 50mg/5ml Ampoule October-1971 Panchronium Bromide 4mg/ml Injection (i.v) April-1971 Panobinostat Hard Gelatin Capsules 10mg/15mg/20mg (Panobinostat lactate) 27.05.2016 Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer) 07.02.07 Pantaprazole sodium 20mg/40mg Tablet (with sodium bicarbonate As buffer) 07.02.07 Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules 17-03-2010 Pantoprazole (40mg) + Domperidone (20mg) ( 10mg IR + 10mg SR) 23-12-2004 Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R 04-08-2006 Pantoprazole (as Sodium) (E.C) 40mg + Itopride (150mg) S.R 8-4-2006 Pantoprazole 20mg EC + Domperidone 10mg Capsules 14.07.2007 Pantoprazole 40mg + Cinitapride (ER) 3mg Capsules 17-03-2010 Pantoprazole 40mg EC + Domperidone 30mg SR Capsules 18.05.2005 Pantoprazole Mouth Dissolving Tablet 20/40 mg 30-03-2010 pantoprazole S(-) (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet 30-08-06 pantoprazole S(-) (as sodium) 20mg (E.C.) + Domperidome SR 30mg tablet 30-08-06 Pantoprazole S(-) (as Sodium) Inj. 20mg/vial 30-08-06 Pantoprazole S(-) (10mg/20mg) tablet 20-05-2005 Pantoprazole Sodium (with Sodium Bicarbonate as Buffer) 28.4.2008 Pantoprazole Sodium (With Sodium bicarbonate as buffer) 20mg/40mg tablets 28.04.08 Pantoprazole Sodium 40mg per vial i.v Injection 7-6-2000 Pantoprazole Sodium IP Eq to Pantoprazole 40 mg (As Enteric coated pellets) + Levosulpiride 75 27.01.14 mg (as sustained release tablets) Capsules Pantoprazole Sodium sesquihydrate eq. Pantoprazole 40 mg/40mg + Domperidone 20mg/20mg( 10 24.12.2004 mg IR+ 10mg SR) Capsule Pantoprazole Sodium Sesquihydrates 40mg/20mg Gastro Resistant Tablet 9-12-1998 Papain + Urea Ointment FDC of 11-07-2005 Papain + Urea Ointment FDC of 07-11-2005 Paracetamol 500mg/500mg +Thioclchicoside 4mg/8mg tablet 21.09.10 Paracetamol 300mg + D-propoxyphene HCl 25mg per tablet Dec-72 Paracetamol 450 mg+Chlormezanone 100 mg tablet Oct-82

PHARMADOCX CONSULTANT 83 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Paracetamol + Meloxicam + Benzyl Alcohol + Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) 30.09.08 Injection Paracetamol + Meloxicam + Benzyl Alcohol + Lignocaine (5mg/ml + 150mg/ml + 1% + 1% ) 30.09.08 Injection Paracetamol + Phenylephrine Hydrochloride (Each 6gm Sachet contains: 500mg + 10mg) Sachet 24.12.08 Paracetamol + Phenylephrine Hydrochloride (Each 24.12.08 6gm Sachet contains: 500mg + 10mg) Sachet Paracetamol 120mg + Diphenylpyralime HCl 1.5mg + Phenylpropanolamine HCl 10mg per 5ml May-76 expectorant Paracetamol 325mg + Tramadol Hydrochloride 21.06.11 37.5 mg Tablets Paracetamol 325mg + Tramadol 21.06.11 Hydrochloride 37.5 mg Tablets Paracetamol 500mg/500mg 21.09.10 +Thioclchicoside 4mg/8mg tablet Paracetamol 650mg SR Tablet August-1996 Paracetamol Bilayer Tablet 1000mg 11.4.12 Paracetamol Chewable Tablet 500 mg. 05.01.11 ( Additional Dosage Form) Paracetamol Fast Release Tablet 500mg 10.02.11 (Additional Dosage Form) Paracetamol IP 325mg + Pamabrom USP 25mg Tablets 07.12.11 Paracetamol IP 325mg + Pamabrom USP 07.12.11 25mg Tablets Paracetamol IP 500mg + Phenylephrine HCL IP 5mg +Caffeine (anhydrous) IP 30mg + 13.10.10 Diphenhydramine HCL IP 25mg tablet. Paracetamol IP 500mg + Phenylephrine HCL IP 5mg 13.10.10 +Caffeine (anhydrous) IP 30mg + Diphenhydramine HCL IP 25mg tablet. Paracetamol Solution for Infusion (10mg/ml) in 50ml (Additional Packsize) 10-02-2010 Paracetamol solution for infusion 10mg/ml 23.12.08 Paracetamol SR 1000mg Bilayered tablet 24-05-2010 Paramethasone Acetate August-1962 Parbendazole (For Veterinary) February-1973 Parbendazole 4%w/w + Ethixygin 0.125% w/w Jun-73 + Extracted soya flour added to 100% suspension Parecoxib Inj. 01.11.2002 Pargyline Hcl. November-1965 Paromomycin 150mg Capsule March-1961 Paromomycin Inj. 375mg/ml 30-08-06 Paroxetine Hcl 4-10-2000 10mg/20mg/30mg/40mg Tablet Parvo Virus Vaccine (Killed) (For Veterinary) March-1989 Parvo-Virus Vaccine (killed) (For Veterinary) October-1986 Pasireotide long-acting release 20/40/60mg powder for suspension for injection (Additional 14.02.2017 Indication) (Pasireotide pamoate) Pasireotide solution for injection 0.3mg/0.6mg/0.9mg 18.03.2015 Paspat Injection 27-5-1993 Pazopanib (as Hydrochloride) film 16.10.10 coated Tablets…200mg / 400mg Pazopanib Tablet 200mg/400mg (additional indication) 23.02.15 Pazufloxacin Mesylate i.v. infusion 300mg/100ml & 500mg/100ml 09.07.08 Pefloxacin Mesylate Dihydrate 0.3% w/v Eye Drops 12-11-1993 Pefloxacin Mesylate Dihydrate 400mg Film Coated Tablet May-1991 Pefloxacin Mesylate Dihydrate 400mg/5ml Injection Pefloxacin Mesylate Dihydrate 400mg I.V Bottles of 100ml/200ml PEG L-Asparaginase (Pegaspargase) Injection 750IU/mL, iv/im (Pack size 5mL/vial) 29.08.2016 Pegaptinib Sodium Injection (0.3mg). 6-2-2006

PHARMADOCX CONSULTANT 84 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Pegasperagase 3,750 IU/5 mL 07 03 2014 PEG-Electrolytes (iso-osmotic laxative) 19-12-1997 Pemetrexed disodium 500mg / 100mg powder for 04.12.08 sol. (Addl. Indication) Pemetrexed Disodium 500mg/100mg Powder for Injection 30.10.12 Pemetrexed Disodium 500mg/100mg Powder for Injection (additional indication) 16-01-2010 Pemetrexed disodium500mg / 100mg powder for sol. (Addl.indication ) 08.10.08 Penamecillin 0.35gm Tablet December-1967 Penfluridol 20mg Tablet March-1988 Pentazocine Lactate 30mg/ml Injection October-1977 Pentazocine (as Lactate) 30mg in 1ml Ampoule (i.v, s.c, i.m) January-1969 Pentazocine base (as Hydrochloride) 50mg Tablet August-1973 Pentosan polysulfate Sodium Cpasules 100mg 11-05-2010 Pentoxifylline September-1975 Pentoxifylline 100mg Dragee November-1975 Pentoxifylline 100mg/5ml Ampoule November-1975 Pentoxifylline 400mg Dragee March-1986 Pentoxyfyline Bulk August-1977 Pentoxyphylline 400mg SR Tablet March-1990 Peracetic Acid (NLT 4.5% ) + Hydrogen Peroxide (NLT 24%) Disinfectant liquid for livestock 01.09.2004 species. Perampanel 2mg/4mg/6mg/8mg/10mg/12mg Tablets 02.12.2016 Perflutren liquid microsphere injectable suspension 31-05-2006 Pergolide Mesylate 50mcg/250mcg/1000mcg Tablet 11-10-2000 Pericyazine February-1968 Pericyazine 2.5mg & 10mg Tablets November-1969 Perindopril 2mg/4mg Tablet September-1991 Perindopril 2mg/4mg+Indepamide 0.625mg/1.25mg tablet 24.03.1998 Perindopril arginine 2.5mg/5mg/10mg film coated tablet 16.05.09 Permethrin 5% Cream 6-3-1995 Phenelzine Dihydrogen Sulphate Tablet November-1961 Pheniramine Maleate Retard Tablet November-1971 Phenprobamate 400mg Tablet March-1964 Phenyl dimethyl isopropyl pyrazolone 150mg + Diethyl dioxotetrahydro pyridine 50mg + Nov-80 Paracetamol 250mg + Caffeine (Anhydrous) 46.75mg Phenyl propalamine HCl 50mg + Isoprapamide 2.5mg + Diphenyl pyralline HCl 5mg capsule Sep-71 Phenylbutazone 125mg + Propyphenazone 125 mg tablets Feb-80 Phenylbutazone Calcium 200mg & 50mg Tablet May-1963 Phenylbutazone Sodium Parentral Form August-1963 Phenylephrine 2.5% Eye drops 02-12-2005 Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + sodium citrate 31.01.08 60mg + Menthol 1mg (per 5ml) Syrup Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + Sodium Citrate 31.01.2008 60mg + Menthol 1mg syrup Phenylephrine 5mg + Chlorpheniramine maleate 0.5mg + Paracetamol 125mg + sodium citrate 60mg 31.01.08 + Menthol 1mg (per 5ml) Syrup

Phenylmethylamine-amino benzene Sulphate 15mg + Phenylmethylamine Hcl 10mg tablet Jul-69 Phenylmethylamine-amino benzene Sulphate 1.5% w/w + Phenylmethylamine Hcl 1.5% w/w Jul-69 ointment Phenylmethylamine-P-Amino Benzene Sulphonate (Basic drug) July-1969 Phenylmethylamine-P-Amino Benzene Sulphonate (25mg/ml) Injection. July-1969 Phenyramidol Hydrochloride 200mg Tablet August-1962 Phenyramidol HCl tablet 400mg 14.11.08 Phenytoin Sodium (300mg) tablet 05-08-2005 Phenytoin Sodium E.R (300mg) 14-6-2007. Phenytoin sodium ER capsules (300mg) (New dosage form) 14.06.07

PHARMADOCX CONSULTANT 85 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Pholcodiene Syrup (4mg/5ml). 06-07-2007. Phospholipids Fraction from Bovine Lung (surfactant) 50 mg/vial 12.09.2016 Pidotimod Tablet 400 mg/800 mg & Oral 11.02.11 Solution 400 mg/800 mg per 7ml Pilocarpine Hcl 40mg/gm Gel 24-6-1999 Pimaricin 50mg Vaginal Tablet December- 1961 Pimcrolimus 10 mg/gm cream 23-07-2004 Pimozide August-1974 Pimozide 1mg/4mg Tablet December-1974 Pinaverium Bromide 50mg Film Coated Tablet April-1990 5mg Tablet November-1973 Pindolol Tablet September-1973 Pinene 17mg+camphene 5mg+Cineol 2mg+Menthone 6mg+Menthol 32mg +Borneol 5mg+Olive Sep-91 oil 33mg capsule Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional strength) 23.01.07 Pioglitazone 15mg/30mg + MetFormin ER 1000mg tablet (additional strength) 23.01.07 Pioglitazone 15mg+Metformin 500mg (O.D.) tablets 18.10.2002 Pioglitazone HCl eq. to Pioglitazone 15mg/15mg+ Glimepiride 1mg/2mg tablet 25.10.2002 Pioglitazone Hcl 15mg/30mg/45mg Uncoated Tablet 17-10-2000 Pioglitazone HCl eq. to Pioglitazone 30mg/30mg+ Glimepiride 1mg/2mg uncoated tablet 13.03.2003 (additional strength) Pioglitazone Hydrochloride Eq. to Pioglitazone 15mg/30mg + Metformin HCl IP 500mg (ER) 25.02.2005 tablets Pioglotazone 15mg/30mg + Metformin500mg/500mg ER Tablet 26.04.2004 Pipazethate 20mg Dragee & 40mg/ml Drops September-1961 Pipecuronium Bromide 4mg per vial Injection 3-11-1992 Pipenzolate methylbromide 5mg Tablet March-1961 Piperacillin Sodium 1gm/2gm/3gm/4gm per vial Injection August-1989 Piperacillin sodium eq. to piperacillin 4gm/2gm 13.08.1999 + Tazobactum sodium 500mg/250mg per vial injection Piperaquine tetraphosphate as Piperaquine Tetraphosphate Tetrahydrate (QP) 320 mg + 18.09.14 Dihydroartemisinin (DHA) 40 mg Each Film coated tablet contains: Piperidolate hydrochloride 50mg Capsule March-1961 Pirarubicin Hcl Injection May-1991 Pirfenidone film coated tablet 14.09.10 ...200mg 50mg S.R Coated Tablet 27-9-1993 Piroxicam 0.5% Gel March-1990 Piroxicam 10mg Capsule August-1986 Piroxicam 20mg tab& Paracetamol 500mg tab combikit 19-01-2010 Piroxicam 20mg tab& Paracetamol 500mg tab combikit 19-01-2010 Piroxicam Betacyclodextrin 20mg Tablet 25-3-1996 Piroxicam Sublingual Tablet 20mg (Additional Dosage Form) 27.12.11 Piroxicam Transdermal Patch March-2000 Piroxicam USP 20mg/ml (i.m) Injection August-1991 Pitavastatin (1mg/2mg) Tablet 14-01-2005 Pitavastatin Tablet 4mg 23.10.12 Pivazide 50mg Tablet September-1961 Plantago Ovate (Isapgol) Seed Husk (IP) and Effervescent Powder March-1981 Plerixafor Injection 20mg/ml 31.01.12 Podophyllotoxin 0.5% each 3-5ml Topical Solution 5-5-1995 Policresulen 50mg+Cinchocaine 10mg per gram ointment 07.07.1995 Polidocanol Injection March-1987 Polio Virus Vaccine Live (Oral) Sabine strain type- I, II, III (0.1ml) November-1962 Polonosetron (As Hcl.) For Injection 0.25mg/5ml 20.03.07 Polyestradiol Phosphate Injection July-1986 Polyethylene glycol 0.4% w/v + Propylene Glycol 0.3% w/v Eye Drops 13.09.11

PHARMADOCX CONSULTANT 86 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Polyethylene glycol 0.4% w/v + 13.09.11 Propylene Glycol 0.3% w/v Eye Drops Polyethylin Glycol 400 (0.4%) + Propylene 18-9-2007. Glycol (0.3%). Polyethylin Glycol 400 (0.4%) + 18-9-2007. Propylene Glycol (0.3%). Polyglycolic Acid Sutures May-1973 Polysachharide Pneumococcal Vaccine (Pneumo 23) 9-7-1996 Polythiazide 2mg Tablet February-1962 Polyvidone 50mg per ml Eye Drops 5% 30-4-1997 Polyvinyl Alcohol 14mg/30mg+Benzalkonium chloride-8.05mg per ml Opthalmic solution 16.05.1996 Polyvinyl Alochol 14mg+Povidone 6mg+Chlorbutanol 5mg per ml eye drops 11.01.1996 Polyvinyl Pyrrolidone Iodine Septembet-1970 Pomalidomide 1mg/2mg/3mg/4mg Capsules & Bulk 01.05.2017 Poractant a 24.12.2002 Posaconazole oral suspension 40 mg/ ml 20-12-2011 (additional Indication) Posaconazole Oral Suspension 40mg/ml 18.7.2009 Potassium Clavulanic Eq. to Clavulanic Acid 125mg + Amoxycillin Trihydrate Eq. to 05.04.1990 Amoxycillin 250mg tablet Povidone Iodine IP 5.0% w/v per ml Sterile Ophthalmic Prep Solution 22-11-1996 Povidone Iodine Ointment USP 10% w/w 15.06.2016 (available Iodine 1%w/w) Water soluble ointment Povidone Iodine Sachet (containing Effervescent Granules) Each 2gm Sachet contains: 175mg 25.08.08 (available iodine 17.5mg) Povidone Iodine USP 4% Scrub September-1978 Povidone Iodine USP 5% Ointment September-1978 Povidone Iodine USP 5% Solution September-1978 P-Piperidinoethoxy-O- Carbomethoxy Benzophenone Hydrochloride,5mg/10mg Injection, Tablet February-1961 & Suppository November-1973 Practolol BP 100mg Tablet January-1974 Pralidoxime Chloride Tablet & Injection March-1966 Pralidoxime Iodide March-1966 Pramipexole Di HCl monohydrate ER Tablet 0.375/0.75/1.5/3/4.5 mg 13-03-2010 Pramipexole Di-hydrochloride Tablet (0.125mg/0.25mg/0.5mg/1mg/1.5mg). 25-07-2005 Prasugrel (as Hydrochloride) film coated tablet ....5 mg / 10mg. 13-04-2010 Prasugrel Hydrochloride IP 10 mg (as film coated tablet) + Aspirin IP(as enteric coated tablets) 75 15.01.14 mg hard gelatine capsule Pravastatin 40mg tablet (Additional strength) 10-8-2006 Pravastatin Sodium 10mg/20mg/40mg Uncoated Tablet 20-12-2000 Praziquantal 20mg+Pyrantel embonate 230mg Tablet ( Veterinary product) 25.11.13 Praziquantel 600mg Tablet August-1985 Praziquantel Tablets February-1986 Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets 30-03-2010 Praziquntel 175mg + Pyrantel 504mg + Febental 525mg Tablets 30-03-2010 Prazocin GITs 2.5mg Tablet 14-9-1999 Hcl 0.5mg/1mg/2mg/5mg Tablet June-1990 Prazosin Hcl (GITS) Tablets 21-6-1995 Prazosin Mesylate 11-3-1999 Prednicarbate 2.5mg per gm Cream 6-8-1997 Prednimustine Tablet July-1986 Prednisolone IP 10 mg Retard Tablet December-1971 Prednisolone Sodium Phosphate Orally Disintegrating Tablet 10/15/30mg 26.11.2009 Prednisolone Stearoylglucolate (6.65mg) Tablet, (1.9g) Ophthalmic Ointment, (1.9g) Cream & February-1971 Ointment Prednisolone Stearoylglycolate November-1970

PHARMADOCX CONSULTANT 87 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Prednisolone10mg + Ofloxacin 3mg per ml eye drop 04.07.2003 Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength) 05.08.2008 Pregabalin 150mg/75mg +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg 12.10.10 +Folic acid 1.5mg capsule Pregabalin 150mg/75mg 12.10.10 +Methylcobalamin 750mcg +Alpha lipoic acid 100mg +Pyridoxine 3mg +Folic acid 1.5mg capsule Pregabalin 75mg/150mg + Methylcobalamin 750mcg capsules (Additional Strength) 08.05.08 Pregabalin capsule (75/150/300mg) 25-11-2005 Pregabalin Capsule 25/50/100/200mg (addl. Strength) 19-05-2006 Pregabalin capsules (Addl. Indication) 29.04.08 Pregabalin SR 75/150/300mg + Methylcobalamin 1500mcg tablets 09-02-2010 Pregabalin SR Tablet 150/300mg 16.05.2009 Pregabalin SR Tablet 75mg (Additional Strength) 30-01-2010 Pregabalin SR75/150/300mg + Methylcobalamin 1500mcg tablets 02-09-2010 Pregabalin-75mg/150mg +Methylcobalamine 500mcg cap 12.10.07 Pregabalin-75mg/150mg 12.10.07 +Methylcobalamine 500mcg cap Premetrexed(Disodium) powder For solution For Inj. 500mg/vial 21-08-06 Premetrxed disodium injection 100mg/vial (Additional Strength) 12.03.08 Prenoxdiazine Hcl 100mg Tablet July-1990 Lactate October-1964 Prenylamine Lactate 60mg Tablet June-1973 Primaquine Tablet 45mg(Additional Strength) 05-05-2011 Procarbazine Hydrochloride USP April-1981 Prochlorperazine Maleate 3mg Buccal Tablet 9-8-1999 Progesterone Micronized Soft Gelatin Capsule 21-6-1995 Promegestone 0.125mg/0.250mg/0.500mg Tablet 23-9-1996 150mg/300mg Tablet January-1987 Propafenone 70mg/20ml ampoule Injection January-1987 Propafenone Hydrochloride November-1986 Propanidiol 0.5gm/10ml Injection July-1970 Propanidiol 5% Solution May-1970 Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution 18-01-2010 Propanol 1-ol 18gm + Ethanol 100% 45gm/100ml solution 18-01-2010 Propanol 50gm+povidone iodine- 1gm in 100ml solution 19.11.07 Propanol 50gm+povidone iodine-1gm in 100ml solution 19.11.07 Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution 19.11.07 Propanol-18 gm+Ethenol(100%)-45gm in 100ml solution 19.11.07 Propionyl-L-Carnitine HCl Tablet (500mg) & injection 300mg/vial 22-03-2006 Propofol 1% for injection (Additi 5.11.2009 Propofol 10 mg+ Lignocaine 2.5 mg per ml injection (addditional Strength) 27.10.2009 Propofol 10 mg+ Lignocaine 2.5 mg per ml injection 27.10.2009 Propofol 10mg + Lignocaem 1mg per ml injection 04.04.07 Propofol 10mg + Lignocaem 1mg per ml injection 04.04.07 Propofol 10mg per ml Injection 18-5-1998 Propofol 2% w/v Injection (additionalStrength) 27-02-2010 Propoxur 1gm + Flomethrion 0.225 gm per 10mg of collor for veternary use 03.02.1997 Propoxyphene Napasylate 100mg + Paracetamol 650mg Capsule Nov-78 Propranalol Hcl 10mg Tablet November-1971 & (1ml) Injection Propranalol Hcl. (10mg/40mg) Tablet & (5mg/5ml & 1mg/ml) Ampoule August-1967 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules 16-03-2010 Propranolol Hcl (10mg/40mg) Tablet & (1mg/ml) Injection October-1972 Propranolol Hcl 80mg Sustained Release Capsule December-1987 Propranolol Hcl 80mg/160mg Sustained Release Tablet September-1985 Propranolol 40mg (SR Pellets) + Fluarizine 5mg/10mg capsules 16-03-2010

PHARMADOCX CONSULTANT 88 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Propranolol 40mg + Hydrallazime 25mg tablet Feb-80 Propranolol HCl 40 mg+HCTZ 25 mg tablets Oct-82 Propranolol Hcl 80 mg+Bendrafluazide 2.5 mg capsule Oct-82 Propyl Docetrizoate (75% w/v) 20ml May-1962 Proresid June-1965 Protein derived from Soya Bean 33.2gm/150gm June-1977 Prothionamide Septembet-1970 Prothionamide 125mg Tablet June-1972 Prothionamide B.P. June-1972 Prothipendyl Hydrochloride 20mg Dragee January-1962 Protokylol Hydrochloride Injection (0.5mg) & Tablet (2mg) July-1961 Protriptyline Hcl. 5mg/10mg Tablets February-1969 Prucalopride 1mg/2mg Tablet & Bulk (Prucalopride Succinate) 13.04.2017 Prulifloxacin (600mg) Tablet. 30-10-2007. Pseudoehedrine HCl 30mg + Ibuprofen 200mg tablet 28.09.1992 Psoralen 10mg + Copper Sulphate 2mg Tablet Oct-71 Purified Chick Embryo Cell (PCEC) Rabies Vaccine (HEP flury virus strain) November-1988 Purified Chick Embryo Cell (PCEC) Tissue Culture Rabies Vaccine November-1985 Purified Chick Embryo Cell (PCEC) Tissue Culture Rabies Vaccine December-1989 Purified Vi-Capsular Polysaccharide of Salmonella Typhi 0.025mg + Phenol 1.250mg + Isotonic 12-2-1993 Buffer Solution q.s 0.5ml (One vaccinating dose of 0.5ml) PVP/VA resin 5% + Benzalkonium chloride 0.10% + Lignocaine HCl 0.25% + D-panthanol DAB- Sep-77 7DDR 2% aerosol pack of 85gm Pygenum Africum 30.07.2002 Pyrantel embonate 14.4mg + Febental 15mg per ml suspension for Veternary use 23.04.2001 Pyrantel Pamoate USP July-1972 Pyrantel Tartrate (For Veterinary purpose) April-1969 Pyrazinamide September-1964 Pyrazinamide 250mg Dispersible Tablet 6-6-1997 Pyridine 3-carboxylic acid hydroxy methylamide 0.125gm + Choline Bitartrate Tablet Jul-71 Pyridoxine Hcl 100mg C.R Tablet 7-5-1992 Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 23.12.2010 500mcg + Chromium Picolinate USP 250mcg Tablet Pyridoxine HCL IP 3mg + Nicotinamide IP 100mg + Cyanocobalamin IP 15mcg + Folic acid IP 23.12.2010 500mcg + Chromium Picolinate USP 250mcg Tablet Pyrimidine (0.5gm) Tablet Pyritinol Tablet April-1965 Pyrvinium Pamoate October-1962 Quetiapen fumarate Sustained Release Tablets 50mg and 100mg (Additional Strength) 05-04-2011 (As fumarate) SR 400mg tablet (additional strength) 05.03.07 Quetiapine fumarate SR tablets 21.02.08 Quetiapine Fumerate 31.05.2002 Quetiapine S.R tablet 200/300mg. 1-8-2006 Quetiapine SR Tablets 50mg ( additional strength) 10.04.07 Quinapril 19.09.2002 Quinapril 20mg + HCTZ 25mg film coated tablet 26.02.09 Quinapril 20mg + HCTZ 25mg film coated tablet 26.02.09 Quinapril HCl eq. to Quinapril 10mg/20mg, Hydrochorothiazide 12.5mg/12.5mg film coated tablet 10.02.2003 Quinapyramine Sulphate B vet C 1.5 g + Quinapyramine Chloride B vet C 1.0g 13.02.15 Injectable dosing Form (veterinary product) Each vial contains: Quinapyramine Sulphate/Chloride (Bulk) August-1980 Quinestrol 25mcg Tablet July-1971 Quinethazone 50mg Tablet January-1964 Phenylethyl Barbiturate (0.1gm) Tablet March-1969 r Human Erythropoeitin 1000IU/ml, 2000IU/ml, 19-6-2000 3000IU/ml, 4000IU/ml, 10000IU/ml Injection R (-) Ondansetron oral Solution (1mg/5ml) 24-05-2005

PHARMADOCX CONSULTANT 89 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

R(-) Ondansetron (2mg/4mg) tablet 15-04-2005 Rabbit Anti Human Thymocyte Immunoglobulin May-1991 Rabeprazole 27.12.2001 Rabeprazole 20mg + Domperidone 30mg SR Capsule 10.08.2004 Rabeprazole (20 mg) + Mosapride S.R. (15 mg) Tablet FDC of 27-07-2004 Rabeprazole 20mg (EC) + Itopride SR 150mg 28-11-06 Rabeprazole 20mg (EC) + Itopride SR 150mg capsule 28-11-06 Rabeprazole 20mg+Mosapride 15mg SR tablet 27.07.2004 Rabeprazole Sodium ( with Sodium bicarbonate as buffer) 28.04.2008 Rabeprazole Sodium (20 mg) 04-10-2004 + Domperidone(30 mg) S.R Capsule FDC of Rabeprazole Sodium (With Sodium bicarbonate as buffer) 10mg/20mg tablets 28.04.08 Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As buffer 26.02.07 Rabeprazole Sodium 20mg/10mg with sodium bicarbonate As buffer 26.02.07 Rabeprazole sodium Enteric coated pellets 15.4% w/w (20mg/129.83mg) 16.04.08 Rabeprazole Sodium Injection 20 mg/vial 12-05-2004 Rabeprazole Sodium Powder oral suspension ( sachet of 20 mg) (Additional dasage form) 03.12.2010 Rabies Vaccine Inactivated November-1988 Rabies Veterinary Vaccine Inactivated (For Veterinary) November-1987 Racecadotril 10.10.2001 Racecadotril dispersible tablet (10mg/30mg) (new dosage Form) 15-12-06 Racecadotril Sachet (10 mg/30 mg) 18-05-2004 Raloxifene HCl 04.05.2001 Raltegravir (as Potassium) film coated Tablets 400mg 27-01-2010 Ramelteon film coated tablets 8mg 15.12.2010 Ramipril 2.5mg/5mg + Losartan Potassium 50mg/50mg tablet 12.09.2003 Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength) 20.02.08 Ramipril (5mg) + Telmisartan (40mg) tablet 11-05-2005 Ramipril (5mg) + Telmisartan (40mg) tablet 05-11-2005 Ramipril 1.25/ 2.5/5/10 mg(Additional Indication) 24-05-2010 Ramipril 1.25mg/2.5mg/5mg/10mg Capsule August-1991 Ramipril 10mg + HCTZ 12.5mg tablet (additional strength) 20.02.07 Ramipril 10mg + HCTZ 12.5mg tablet (additional strength) 20.02.07 Ramipril 2.5mg/5mg+Hydrochlorothiazide 12.5mg/25mg tablet 26.08.1996 Ramipril 2.5mg+S(-) Amlodipine Besylate eq. to S(-) Amlodipine 2.5mg tablet and capsule 11.02.2003 Ramipril 5mg + HCTZ 12.5mg tablets (Additional Strength) 20.02.08 Ramipril BP 2.5mg/5mg + Telmisartan 40mg uncoated tablet 11.12.2007 Ramipril BP 2.5mg/5mg+Candesartan cilexatil eq. to candesartan 8mg/8mg bilayer tablet 01.08.2003 Ramipril MR capsule 10mg 30.7.2009 Ramipril MR Capsules 2.5/5 mg (Additional Strength) 03-07-10 Ramosetron Dispersible Tablet 0.1 mg 12-06-2010 Ramosetron Hydrochloride Tablets 2.5mcg, 5mcg, 0.1mg & Injecton 0.3mg /2ml 11.11.2009 Ranitidine Hydrochloride 50mg/2ml Injection February-1986 Ranitidine 150mg/10ml Syrup February-1990 Ranitidine Hcl 150mg Tablet August-1985 Ranolazine 1000mg ER Tabs (Additional Strength) 31.01.09 Ranolazine ER Tablet 375mg/750mg (Additional 11-08-2011 Strength) Ranolazine ER Tablets 750mg (Additional Strength) 24-04-2010 Rasagiline (as mesylate ) Tablet 0.5mg/1mg 31.01.09 Raubasine 10mg+ Almitrine 30mg film coated tablet 11.08.2003 rDNA Hepatitis B Vaccine (10mcg) 15-9-2000 Rebamipide 100 mg tablet 28-07-2004 RebamipideOphthalmic suspension 2%w/v Each mL contains : Rebamipide 20mg 11-11-2016 Benzalkonium Chloride IP 0.01%w/v (as preservative) Reboxetine 31.12.2002 Recombinant Human Erythropoietin (r Hu Epo) 12-7-2000

PHARMADOCX CONSULTANT 90 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Recombinant Human Erythropoietin (r-Hu Epo) 7-2-2000 Recombinant Human Tissue Type Plasminogen Activation (Actilyse) 20mg/50mg per vial Injection July-1989 Recombinant Interferon Alpha- 2b 27-12-2000 3mIU/5mIU/10mIU/18mIU/ 25mIU Injection Regorafenib film coated tablet 40 mg 01 07 14 Renolazine Extend ReleAse tablet (500mg) 14.06.07 Hcl 0.50mg each metered dose Aerosol October-1987 Reproterol Hcl 0.09mg/ml Injection October-1987 Reproterol 10mg/5ml Syrup January-1987 Reproterol 20mg Tablet January-1987 Reproterol Hcl 10mg/5ml Elixir October-1987 Reproterol Hcl 10mg/ml Respirator Solution October-1987 Reproterol Hcl 20mg Tablet October-1987 Reproterol Hydrochloride September-1986 Reserpine 0.1mg + Clopamide 5mg + Dihydroergocristine 0.5mg Tablet Jan-72 Resperidone 1mg/2mg/3mg/4mg Film Coated Tablet 3-4-1997 Resperidone 1mg/ml Liquid 14-5-1997 Resperidone E.R. (long-acting) injection (12.5mg/vial) (addl. strength). 25-09-2007. Resperidone Tablet & Syrup (addl. Ind ) 4-4-2006 Retapamulin Ointment 1% 25.04.2009 r-Follicle Stimulating Hormone (FSH) 19-8-1999 rHuman Erythropoeitin 2000IU/4000IU per vial Injection 8-11-2000 Ribavirin 100mg/200mg Capsule and Ribavirin 50mg/5ml Syrup November-1990 Ribavirin Capsules 200mg (Addl. Strength) 24.12.2009 Rifabutin Capsule (150mg). 16-07-2007. Rifampicin +Piperine (200mg + 10mg ) Capsules 11.12.08 Rifampicin 75mg Isoniazid 50mg dispersible tablet (additional strength) 11.03.16 Rifampicin - 75mg Isoniazid -50mg Pyrazinamide -150 mg dispersible tablet (additional strength) 08.03.16 Rifampicin + INH + Piperine (200mg + 300mg + 11.12.08 10mg ) Capsules Rifampicin + INH + Piperine (200mg + 300mg 11.12.08 + 10mg ) Capsules Rifampicin +Piperine (200mg + 10mg ) Capsules 11.12.08 Rifampicin 150mg/300mg Capsule September-1971 Rifampicin 450mg June-1971 Rifampicin syrup June-1983 Rifampicin300mg/450mg/600mg+INH 200mg/300mg/300mg Jun-83 Rifaximin 400mg (additional Indication) 18.7.2009 Rifaximin Dispersible Tablet 200mg 26.11.2009 Rifaximin Oral Suspension 100mg/5ml (New 09-06-2011 Dosage Form) Rifaximin Tablet 550 mg (Additional strength and 18-08-2011 Additional Indication) Rifaximine 200mg tab. 28-08-06 Dihydrogen Phosphate 1mg Tablet 21-2-1995 Riluzole Tablets 17-10-1997 Rimonabant tablet 20mg 11.05.07 Ripaglinide 0.25mg/0.5mg/1.0mg/2mg Tablet 23-3-2000 Risedronate Sodium 17-10-2003 Risedronate Sodium 150mg Tablet (Additional Strength) 16.09.08 Risedronate Sodium tablet (35mg) (additional indication) 08-10-2007. long acting injection (Addl. Indication) 29.08.2009 Risperidone long-acting suspension for injection 25 mg/37.5 mg/50 mg per vial 26-08-2004 Risperidone prolonged release suspension for injection (Deep Intramuscular Deltoid route using 19.12.13 appropriate safety needle) (Additional route of administration) Hcl 10mg Tablet Ritodrine Hcl USP 10mg/ml Injection 21-2-1995

PHARMADOCX CONSULTANT 91 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Ritonavir 20mg + Lopenavir 80 per ml oral solution 18.01.2001 Ritonavir 33.3mg + Lopenavir 133.3mg soft gelatin capsule 18.01.2001 Ritonavir 100mg Capsule 8-9-1997 Rituximab 10mg/ml vial (Concentrate for solution for infusion) 10-7-2000 Rivaroxaban film coated Tablets 10mg 30-01-2010 Rivaroxaban tablet 15/20mg (Additional strength/indication) 2.9.14 Rivaroxaban tablet 2.5mg (add. strength) 13.07.15 Rivastigmine Hydrogen Tartrate 0.5mg/1mg/1.5mg/3mg/4mg/ 5mg/6mg Capsule 31-7-1998 Rivastigmine transdermal patch (each patch of 5m2, 10m2,15m2 & 20m2 contain Rivastigmine base 28.01.08 9/18/27/36mg respectively Rivastigmine transdermal patch. 28-10-2014 EachTranstermal patch of 15cm2 contains Rivastigmine 27mg (Additional indication) Rizatriptan 27.02.2003 Rizatriptan Benzoate orally disintegrating tablet 10 mg(Additional Dosage Form) 24-05-2010 Rocuronium Bromide 50mg/5ml & 100mg/10ml Injection 18-6-1996 Rofecoxib 12.5mg/25mg per 5ml Oral Suspension 25-9-2000 Rofecoxib 12.5mg/25mg Uncoated Tablet 26-6-2000 Tab 500 mcg 17 07 14 R-Ondansetron (As Hcl. Dihydrate) (1mg/ml) injection 12.01.07 Ropinirole 03.12.2001 Ropinirole 6mg ER Tablets (Addl. Strength) 06-02-2010 Ropinirole ER Tablet 1 mg. 04.01.11 (Additional Strength) Ropinirole ER tablet 2/4/8mg 3.12.2009 Ropivacaine HCl Inj.2/5/7.5/10 mg 19.03.09 Rosiglitazone 1mg + Metformin Hcl 500mg tablet (additional strength) 08.02.07 Rosiglitazone 4mg+Metformin 500mg tablet 21.02.2002 Rosiglitazone maleate eq. to Rosiglitazone 2 mg+Metformin IP 500mg tablet 11.10.2001 Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg tablet 8-8-2006 Rosiglitazone (as maleate)2mg + Glibenclamide 5mg + MetFormin 500mg tablet 08-08-2006 Rosiglitazone 1mg + Metofmin Hcl 500mg tablet (additional strength) 08.02.07 Rosiglitazone 2mg/4mg/8mg Tablet 14-7-2000 Rosiglitazone 2mg/4mg+Metformin SR 1000mg/1000mg tablet 20.05.2003 Rosiglitazone maleate eq. to Rosiglitazone 2mg+Glimepiride 1mg tablet 14.11.2002 Rosiglitazone Maleate 1mg/2mg/4mg/8mg Film Coated Tablet 28-6-2000 Rosiglitazone maleate eq.to Rosiglitazone- 2mg/4mg+ Metformin HCl (SR) 500mg /500mg Tablet 11.09.2002 Rosoxacin 150mg Capsule July-1982 Rosuvastatin 12-09-2003 Rosuvastatin 5/10mg +Fenofibrate 145/67 mg Tablet 23.08.10 Rosuvastatin calcium eq. to Rosuvastatin 10mg + Ezetimibe 10mg tablets 23.02.2007 Rosuvastatin Calcium IP eq to Rosuvastatin 5mg + Ezetimibe 10mg. (Additional Strength) 05.12.11 Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mg 23-08-10 Rosuvastatin 5/10/20mg+Fenofibrate 67/145/160mg Tablet 23-08-10 Rosuvastatin 5/5/5/10/10/10/20mg + Fenofibrate 67.5/145/160/67.5/145/160/160mg Tablet 19.02.2011 Rosuvastatin Calcium eq. to Rosuvastatin 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets 24.08.11 Rosuvastatin Calcium eq. to Rosuvastatin 24.08.11 20mg/20mg + Fenofibrate BP 67.5mg/145mg Tablets Rosuvastatin Calcium IP 5mg/10mg + Fenofibrate BP 160mg/160mg tablet (Additional 29.12.2010 strength) Rosuvastatin Calcium IP 5mg/10mg 29.12.2010 + Fenofibrate BP 160mg/160mg tablet Rosuvastatin Calcium IP eq to Rosuvastatin 05.12.11 5mg + Ezetimibe 10mg. (Additional Strength)

PHARMADOCX CONSULTANT 92 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Rosuvastatin calcium IP 16.06.2016 Eq. to Rosuvastatin (as film coated immediate release tablet) 5mg/10mg Choline Fenofibrate IP Eq. to Fenofibric acid (as delayed release tablets) 135mg/135mg Each Hard gelatin capsule contains:

Rosuvastatin Calcium Tablet(Additional Indication) 24-05-2010 Rosuvastatin Calcium tablets 5/10/20/40mg (Addl. 08.11.08 Indication) Rosuvastatin Calcium Tablets 5/10/20mg 05-04-2011 (Additional Indication) Rosuvastatin Calcium 08.08.2016 Eq. to Rosuvastatin (as film coated tablet) 20mg/20mg Aspirin (as enteric coated tablet) 75mg/150mg (Additional strength) Each Hard Gelatin Capsules contains: Rosuvastatin film coated Tablets 30 mg 30.05.2017 Rosuvastatin Tablets 15 mg 30.05.2017 Roxatidine Acetate Hcl 75mg SR Tablet May-1991 Roxithromycin 150mg/300mg Film Coated Tablet 27-3-1992 Roxithromycin 50mg Kid Tablet Roxithromycin 50mg Dispersible Tablet Roxithromycin 50mg/5ml Dry Syrup Roxithromycin 75mg Tablet 15-5-2000 R- Capsule (2.5mg/5mg) 26-09-2007. Rupatadine (10mg) tablet 05-04-2005 Rupatadine 10 mg + Montelukast 10 mg Tablets 10.11.2009 Rupatadine 10 mg + Montelukast l0 mg Tablets 10.11.2009 Ruxolitinib 10mg tablet (additional Strength) 29.05.15 Ruxolitinib Tablet 5mg/15mg/20mg 28.01.2013 Ruxolitinib Tablet 5mg/15mg/20mg (Additional indication) 23.02.15 Sacubutril+ Valsartan film coated tablets 50mg/100 mg/200mg 14.07.2016 Salazopyrin 500mg Enteric Coated Tablet November-1990 Salbutamal Sulphate 4mg Tablet February-1973 Salbutamol Sulphate 2mg/5ml Elixir October-1974 Salbutamol Sulphate 50mg/5ml Injection January-1979 Salbutamol Sulphate B.P October-1971 Salbutamol Sulphate B.P 8mg Sustained Release Tablet March-1980 Salbutamol sulphate eq. to Salbutamol 100mg + 06.03.2000 +Ipratropium Bromide BP 200mcg inhaler Salcatonin July-1978 Salicylazosulphapyridine 0.5mg Tablet August-1967 Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion 18.12.08 Salicylic Acid + Coal Tar + Precipitated Sulphur (3% + 1% + 3%) Ointment 17.11.08 Salicylic Acid + Cetyl Alcohol + Stearyl Alcohol (2% + 2.65% + 0.26%) Lotion 18.12.08 Salicylic Acid + Coal Tar (3% + 1%) Solution 17.11.08 Salicylic Acid + Coal Tar (3% + 1%) Solution 17.11.08 Salicylic Acid + Coal Tar + Precipitated Sulphur 17.11.08 (3% + 1% + 3%) Ointment Salicylic acid 10mg/20mg (Foaming facewash solution) 28.01.08 Salinomycin Bulk January-1989 Salinomycin Sodium 6% Premix (For Veterinary) December-1988 Salmeterol Xinafoate 25mcg Inhaler Salmeterol Xinafoate 50mcg Rotacap 1-12-1993 Salmeterol (as Xinofoate) 25mcg/25mcg/25mcg+Fluticasone Propionate BP 05.07.2001 50mcg/125mcg/250mcg per actuation Inhaler Salmeterol Xinafoate eq. to Salmeterol 25mcg+Fluticasone propionate 50mcg/125mcg/250mcg per 09.11.2000 actuation Salmon Calcitonin 100 IU/ml each ampoule Injection Salmon Calcitonin 400 IU/2ml each vial 3-8-1995 Injection Saquinavir (500mg) tablet (addl. Strength) 20-03-2006

PHARMADOCX CONSULTANT 93 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Saquinavir (as mesylate) 500mg Tablet 25-07-2005 Saquinavir Capsule 26-8-1997 Sarcolysin April-1965 Sarcolysin I.P. June-1972 Saroglitazar 2mg/4mg Tablets 25.2.13 Sarpogrelate Hydrochloride film coated Tablets 100mg 16-01-2010 S-Atenolol 11-09-2003 Satranidazole (300mg) + Ofloxacin (200mg) Tablet. 18-10-2007. Satranidazole (300mg) + Ofloxacin (200mg) Tablet. 18-10-2007. Satranidazole 150mg Tablet November-1985 Saxagliptin (as HCl) 2.5mg/ 5mg Tablets 24.10.09 Saxagliptin Hydrochloride eq. to Saxagliptin 5 mg Metformin Hydrochloride IP 1000mg (Extended 07.01.15 Release Tablet) (Additional strength) Each film coated tablet contains: S-Bupivacaine Hydrochloride Injection 28.04.11 2.5mg/5mg/7.5mg per ml Secnidazole 500mg Tablet Secnidazole 1gm Film Coated Tablet 13-5-1993 Secnidazole 500mg/15ml Suspension Selamectin Tropical solution (forverterinary use.) 60mg/120mg per ml 09.01.09 Hcl 5mg Uncoated Tablet August-1991 Semduramicin Sodium 50gm per kg Premix 5% (For Veterinary) 4-3-1998 Septopal Beads and Chains January-1985 Tablets 40mg/80mg 30.11.12 Serenoa Repens 160mg Lipid Extract Soft Gelatin Capsule 12-9-1997 Serratio Peptidase 5mg Tablet September-1985 Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo 05-03-2010 Sertaconazole 2% w/v+ Zinc Pyrithione 1% w/v Shampoo 03-05-2010 Sertaconazole Nitrate Cream 2%, 31.01.08 Sertaconazole Nitrate Powder 2% w/w & Lotion 2% w/v 02.05.2009 Sertaconazole Nitrate Vaginal Tab.500mg 09.10.08 Sertanidazole-300mg+ Ofloxacin- 200mg tablet 29.11.07 Sertanidazole-300mg+ Ofloxacin-200mg tablet 29.11.07 Sertraline Hcl 50mg/100mg Tablet 9-6-1998 Sertraline Hcl 25mg Tablet 9-6-1998 Sevelamer (400mg/800mg) tablet 20-05-2005 Sevelamer Carbonate (Additional Indication) 26.11.2009 Sevelamer Carbonate 400mg/800mg tablets & sachet 400mg/800mg 28.04.08 Sevoflurane Inhalation 9-7-1996 Sheep Pox Vaccine (For Veterinary) April-1991 Sibutramine Hcl Monohydrate 5mg/10mg/15mg Capsule 23-12-1999 Sildenafil Citrate 08.01.2001 Sildenafil Citrate 20mg Tablet 23.01.07 Sildenafil Citrate Injection 0.8mg/ml 5.12.12 Sildenafil Citrate Orally Disintegrating Strips. 25mg/50mg (Additional Dosage Form) 05.07.2013 Capsules2mg/4mg/8mg 23.06.11 Silodosin Tablets 4mg 10.4.12 Silver Sulphadiazine 1%w/w Cream September-1979 Silver Sulfadiazine IP (Nanonized) 0.5% 06.07.2017 w/w Chlorhexidine Gluconate Sloution IP eq. to Chlorhexidine Gluconate 0.2% w/w Topical cream

PHARMADOCX CONSULTANT 94 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Silver Sulfadiazine IP (Nanonized) 0.5% 06.07.2017 w/w Chlorhexidine Gluconate Sloution IP eq. to Chlorhexidine Gluconate 0.2% w/w Topical cream Silver Sulphadiazine Ophthalmic Ointment 1% April-1988 Silver Wound Dressing 16.04.08 Silymarin 70mg/140mg Sugar Coated Tablet 22-6-1995 Simethicone (5ml) Gel & Tablet July-1967 Simethicone (methyl polysiloxane) October-1964 Simethicone Orally disintegrating strip 62.5mg 14.11.2010 Simvastatin (10/20mg) + Ezetimibe (10mg/10mg) Tablets 05-11-2005 Simvastatin (10/20mg) + Ezetimibe (10mg) Tab 11-05-2005 Simvastatin 20 mg + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC 21.7.2009 Pellets) Capsules Simvastatin 20 mg 21.7.2009 + Ramipril 5mg + Atenolol 50 mg + HCTZ 12.5 mg + Aspirin 100 mg (EC Pellets) Capsules Simvastatin 5mg/10mg/20mg/40mg Tablet 25-9-1997 Sirolimus 15.07.2002 Sisomicin Sulfate April-1981 Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets 28.04.08 Sitagliptin ( As Phosphate) 50mg + Metformin Hcl. 500mg/1000mg Film coated tablets 28.04.08 Sitagliptin Phosphate 25/50/100 mg Tablet (Additional Indication) 03-07-10 Sitagliptin Tablet (25mg/50mg/100mg). 30-10-2007. Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets 22.01.08 Smatriptan (as succinate ) 50mg + Naproxen sodium 550mg tablets 22.01.08 S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ 11-11-2005 (12.5mg) Tablet. FDC of S-Metoprolol Succinate Oral Solution (Each Ml contains: S-Metoprolol Succinate 9.5mg equal to S- 19.08.08 Metoprolol Tartrate 10mg) S-Metoprolol Succinate Tartrate equivalent to Metoprolol Tartrate (E.R) 25/50mg + HCTZ 11-11-2005 (12.5mg) Tablet. FDC of Sod. Chloride 20.047mg + Pot. Chloride 0.522gm + Mag. Chloride 0.366gm + Cal. Chloride Nov-78 0.859gm + Sod. Acetate 19.047gm per 100ml Dialysis fluid Sod. Chloride 20.475mg + Pot. Chloride 0.783gm + Mag. Chloride 0.534gm + Cal. Chloride Nov-78 0.972gm + Sod. Acetate 19.054gm per 100ml Dialysis fluid Sod. Chloride 558mg + Pot. Chloride 14.9 mg + Mag. Chloride 10.16mg + Cal. Chloride dihydrate May-73 21.9mg + 20/6 Molar Sod. Lactate 1.34 ml + Dextrase Anhydrous 1.5gm per 100ml Sodium Fluoride B.P. 20mg Enteric Coated Tablet August-1975 Sodium Valporate Tablet/Syrup 17-7-2000 Sodium and Maglumine Iothalamate (Meglumine Iothalamate 52% w/v, Sodium Iothalamate 26% July-1969 w/w) - 20ml Ampoule Sodium Chloride 20% Hypertonic saline for intra- amniotic use October-1975 Sodium chloride 6.80gm + Potassium chloride 0.30 gm + Calcium chloride dihydrate 0.37gm + 11-02-2010 Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion Sodium chloride 6.80gm + Potassium chloride 02-11-2010 0.30 gm + Calcium chloride dihydrate 0.37gm + Magnesium chloride hexahydrate 0.20gm + Sodium acetate trihydrate 3.27gm + L-malic acid 0.67gm in 1000ml solution for infusion Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection 14.05.08 (additional strength) Sodium Chondroitin sulfate 40mg + sodium Hyaluronate 30mg per ml Intraocular Injection 14.05.08 (additional strength) Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml) 25.08.08

PHARMADOCX CONSULTANT 95 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Sodium Chondroitin Sulphate + Sodium Hyaluronate injection (40mg + not more than 17mg per ml) 25.08.08 Sodium Cromoglucolate November-1972 Sodium Cromoglycate (Bulk) May-1976 Sodium Dichloro Isocyanurate 35mg/350mg/1.75g/3.5g Tablet 12-6-2000 Sodium Enoxaparin Low Molecular Weight Heparin 20mg/40mg Injection 13-3-1992 Sodium Ferric Gluconate complex with sucrose eq. to elemental iron 6.25mg (12.5mg/ml) 05.09.2002 Sodium Fusidate 20mg/gm Ointment May-1974 Sodium Hyaluronate 0.1% eye drops (addl. Strength) 10-11-2005 Sodium Hyaluronate 10mg/ml Solution June-1989 Sodium Hyaluronate 30mg + Chodroitin Sulfate 40mg each ml opthalmic solution 04.04.2000 Sodium Hyaluronate Cream 0.2% 16-03-2006 Sodium Hyaluronate injectable gel (each 0.6ml. 1ml pre filled syringe contains, sodium Hyaluronate 03.06.08 20mg/ml, 22.5mg/ml Sodium Hyaluronate Injectable Gel 14mg/ml, 18mg/ml, 25.5mg/ml (Additional Strength) 06-02-2010 Sodium Hyaluronate Injection (1%). 26-07-2006 Sodium Hyaluronate Injection 8mg/vial (6ml Pre-filled syringe for Intra Articular use only) 23.4.12 Sodium Iothalamate August-1965 Sodium Iothalamate Oral Solution 60% w/v (eq.to 360mg of Iodine per ml) June-1969 Sodium Nitroprusside USP 50mg/Vial Injection July-1979 Sodium Picosulphate 5mg/10mg Uncoated Tablet Sodium Picosulphate 5mg/5ml Syrup 11-2-1997 Sodium Picosulphate 5mg+liquid Paraffin 4.8ml liquid paraffin per 15ml solution 09.11.2001 Sodium Polyhydroxy Aluminium Monocarbonate Hexitol Complex (360mg) Tablet May-1963 Sodium Pyrolidone Carboxylic acid 2.5% w/w+ Sodium Lactate solu. Eq. to Sodium Lactate 2.5% 15.04.2002 w/w+Vit. E 1% w/w+ Olive Oil 3% w/w cream Sodium Salicylate IP (Eq. to Salicylic acid IP 0.86% w/w) 1.0% w/w + Zinc Gluconate BP 0.5 08.06.15 % w/w + Pyridoxine HCl IP 0.5% w/w (Shampoo) (veterinary product) Sodium Salt + Methyl Glucamine Salt of Diatrizoate (40:18) Injection December-1978 Sodium salt of loxitalamic acid 5.13gm + Meglumine salt of loxitalamic acid 10.26gm per 20ml Inj. Sep-77 Sodium Tolbutamide Injection November-1962 Sodium Valporate Freeze Dried Powder 400mg/ml Injection 20-7-1999 Sodium Valproate October-1981 Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg 24.01.08 C.R. tablet (Additional Strength) Sodium Valproate (750mg/1000mg) C.R. Tablet 26-08-2005 Sodium Valproate (Bulk) October-1981 Sodium valproate 333mg/133.5mg + Valproic acid 145mg/58.0mg corresponding to Sodium 23.08.99 Valproate 500mg/200mg Film coated CR Tablets Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate- 750mg CR 24.01.08 tablet (Additional Strength) Sodium Valproate 499.5mg + Valproic acid 217.5mg equivalent as sodium valproate- 750mg CR 24.01.08 tablet (Additional Strength) Sodium Valproate 666mg + valproic acid 290mg equivalent as sodium valproate 1000mg C.R. 24.01.08 tablet (Additional Strength) Sodium-Iron Edetate 55mg Syrup August-1961 Sofalcone Capsule (100mg/50mg) 02.06.08 Sofosbuvir 400 mg film coated Tablet 16.02.2017 Sofosbuvir 400 mg film coated Tablet 16.02.2017 Sofosbuvir Tablet 400 mg 13.01.2015 Solifenacin Succinate Tablet (5mg/10mg). 6-7-2006 Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. 23.12.2010 Before reconstitution: • 1000ml of electrolyte solution in Compartment A contains Calcium Chloride. 2H2O .....5.145gm, Magnesium Chloride. 2H2O.... 2.033gm, Lactic Acid....5.4gm, • 1000ml of buffer solution in Compartment B contains: Sodium Chloride....6.45gm, Sodium Bicarbonate....3.090gm )

PHARMADOCX CONSULTANT 96 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Solution for haemofiltration and haemodialysis (Each unit contains two compartments A & B. 23.12.2010 Before reconstitution: • 1000ml of electrolyte solution in Compartment A contains: Calcium Chloride. 2H2O .....5.145gm Magnesium Chloride. 2H2O.... 2.033gm Lactic Acid....5.4gm • 1000ml of buffer solution in Compartment B contains: Sodium Chloride....6.45gm Sodium Bicarbonate....3.090gm ) Somatostatin i.v Infusion 24-4-1995 Somatropin (r human growth hormone) 24IU/8mg 20-12-2000 Somatropin (rDNA) 4IU/16IU per vial Injection iSomatropin (rDNA) 18IU/36IU/72 IU per 4-2-1998 cartridge Injection Sorafenib (as Tosylate) (200mg) Tablet. 31-07-2007. Sorafenib tablets 200mg (Additional Indication) 22.01.08 Sorafenib tosylate tablet 200mg (Additional indication) 25.9.14 Sorbide Nitrate 10mg Tablet April-1962 August-1978 Soyabean oil USP 10.0gm+ Egg Lecithin 0.60gm+ Glycerol IP 2.5gm per 100ml Intravenous 28.08.2000 solution Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive oil purified fish oil 30gm + dl- 19-01-2010 alpha-tocopherol 163-225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. Soybean oil 60gm + Triglycerides (medium chain) 50gm + olive 19-01-2010 oil purified fish oil 30gm + dl- alpha-tocopherol 163-225mg + glycerol (anhydrous) 25gm + Egg lecithin 12gm + sodium hydroxide (to approx pH 8) + sodium pleate 0.3mg emulsion for infusion in 100ml. Sparfloxacin 100mg/200mg/400mg Tablet 11-11-1996 Spectinomycin Hydrochloride September-1985 Spenglersan Colloid G 2-6-1997 Sphaeranthus Indicus Extract Tablets 700mg 08-01-2010 Spiramycin 0.75MIU/1.50MIU+Metronidazole 1.25mg/250mg film coated Tablets 15.03.1994 Spiramycin Injection November-1971 Spiranolactone 100mg Tablet March-1961 Spironolactone 25mg + Furosemide 20mg tablets 03-05-2010 Spironolactone 25mg + Furosemide 20mg tablets 05-03-2010 Spironolactone IP 25mg + Furosemide IP 40mg Tablet 05.01.11 Spironolactone IP 25mg + Furosemide IP 05.01.11 40mg Tablet Stanazolol June-1965 Stanozolol 2mg Tablet March-1973 Stanozolol 50mg/ml Injection September-1987 Stavudine 10mg + Lamivudine 40mg + Nevirapine 70mg Dispersible Tablet 11.11.2005 Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tablet 11-11-2005 Stavudine 10mg+Lamivudine 40mg+ Nevirapine 70mg dispersible tablet 11-11-2005 Stavudine 15mg/20mg/30mg/40mg Capsule 12-7-1997 Stavudine 30mg/40mg + Lamivudine 150 mg 26.07.2001 /150mg+ Neviramine 200mg/200mg tablet Stavudine 6mg/12mg + Lamivudine 30mg/60mg Dispersible Tablet 08.05.2005 Stavudine powder for suspension 11-03-2005 Stavudine SR 100mg tablet 29-08-06 Sterile Amoxyllin Sodium eq. to Amoxycillin 500gm/1gm+Sterile Sulbactam Sodium eq. to 21.06.1996 Sulbactam 250mg/500mg (each vial) inj. (IM/IV) Sterile Cefotaxime sodium USP eq. to Cefotaxime 500mg/1000mg+Sterile Sulbactam 26.12.2003 250mg/500mg per vial injection Sterile Morepenam IP eq. to Anhydrous Meropenam 1000mg +Sterile Sodium Carbonate IP Eq. to 13.02.15 Sodium 90.2 mg +Sterile Sulbactum Sodium USP eq. to Sulbactum 500 mg injection (veterinary product) Each Vial contains

PHARMADOCX CONSULTANT 97 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Sterile powder of colistin sulphomethate sodium eq. to 1000000 Units + Dilucame HCl 2mg per vial Feb-80 Inj. Sterile Solution for Peritoneal Dialysis Each 1000 ml contains: Calcium chloride dihydrate 0.184 18.04.12 g/l + Glycine 0.51 g/l + L- Alanine 0.951 g/l + L- Arginine 1.071 g/l + L- Isoleucine 0.85 g/l + L- Histidine 0.714 g/l + L- Leucine 1.02 g/l + L- Lysine (as Hcl) 0.955 g/l + L-Methionine 0.85 g/l + L- Phenylalanine 0.57 g/l + L-Proline 0.595 g/l + L- Serine 0.51 g/l + L- Threonine 0.646 g/l + L-Tryptophan 0.27 g/l + L-Tyrosine 0.3 g/l + L-Valine 1.393 g/l + Magnesium chloride hexahydrate 0.051 g/l + Sodium chloride 5.38 g/l + Sodium lactate 4.48 g/l Sterillium Rub in Disinfectant for Hands. 20-5-1992 Streptococcus faecalis 30million + Clostridium butyricum 2million + Bacillus mesentericus 15.03.2010 1million+ Lactic acid bacillus 50million (lactobacillus sporogenes) Capsules Streptococcus faecalis T-110 JPC 30 million + Clostridium butyricum TO- A 2 million + Bacillus 15-03-2010 mesentericus TO-A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million Capsules Streptococcus faecalis T-110 JPC 30 million + Clostridium butyricum TO-A 2 million + Bacillus 15-03-2010 mesentericus TO-A JPC 1 million + Lactic acid bacillus (lactobacillus sporogenes) 50 million Capsules Streptococcus thermophilus 45% + Bifidobacteria (B.longum, B.infantis,B.breve) 45% + 01.08.2007 Lactobacillus acidophillus 3% + Lactobacillus casei 2% + Lactobacillus delbruecki susp. 3% Bulgaris 2% + Lactobacillus plantarum Streptococcus thermophilus 45% w/w + Bifidobacteria (B.longum, B.infantis,B.breve) 45% w/w + 31.01.2008 Lactobacillus acidophillus 3% w/w + Lactobacillus casei 2% w/w + Lactobacillus delbruecki susp. Bulgaris 3% w/w + Lactobacillus plantarum 2% w/w capsules Streptokinase-Streptodornase Oral Tablet April-1963 Strontium Ranelate Granules (2gm/Sachet) 14-06-2005 Sucralfate 0.07gm + Metronidazole 0.01gm+ Lignocaine 0.04gm per gram cream 23.08.2004 Sucralfate 0.07gm +Metronidazole 0.01gm cream 29.04.2002 Sucralfate (7%) + Povidone Iodine (5%) Ointment 18-08-2005 Sucralfate (7%) + Povidone Iodine (5%) Ointment 18-08-2005 Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per gram of Ointment. 09-10-2007. Sucralfate (70mg ) + Metronidazole (10mg) + Povidone Iodine (50mg) per gram of Ointment. 09-10-2007. Sucralfate 1gm Tablet November-1986 Sucralose 09.05.2009 Sufentanil Citrate 17-12-2003 Sulbactam Sod. Eq. Sulbactam 1000mg 04.04.2000 + Cefoperazone sodium Eq. Cefoperazone 1000mg each vial injection (IV/IM) (Additional Strength)

Sulbactam Sod. Eq. Sulbactam 500mg+ Cefoperazone sodium Eq. Cefoperazone 500mg each vial 16.03.2000 injection (IV/IM) Sulbutiamine 200mg Sugar Coated Tablet 22-4-1196 Sulfametopyrazine June-1978 Sulfametopyrazine 500mg + Pyrimethamine 25mg tablet May-78 Sulfinpyrazone Bulk September-1977 Sulperazone (Sulbactam Sodium) + Cefoperazone Sodium 06.03.2000 Sulphachloropyrazine Sodium 30% (For Veterinary) 18-10-1993 Sulphadiazine 200mg+Trimethoprim 40mg suspension Jan-87 Sulphadiazine 400mg+Trimethoprim 80mg tablet Jan-87 Sulpha-dimethyl Oxazole (Sulfamoxole) 0.5gm Tablet March-1962 Sulphadoxine April-1981 Sulphamethoxy Diazine February-1965 Sulphinpyrazone 100mg Tablet September-1977 Sulphinpyrazone 200mg Capsule September-1977 Sulphur Hexafluoride Powder and solvent for dispersion for injection (45mcg/ml). 28-09-2007. Sulpiride 50mg/200mg Capsule 26-10-1999

PHARMADOCX CONSULTANT 98 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Sulprostone 500mcg per ampoule Injection February-1987 Sulprostone Injection January-1986 Sultamicillin(as Tosylate) 375mg eq. Sulbactam 06.05.1994 147.0 mg + Ampicillin 220 mg Film coated tablets. Sulthiame 200mg Tablet June-1967 Sumatriptan (as Succinate) 100mg/50mg/25mg Film Coated Tablet 6-2-1996 Sumatriptan as Succinate 6mg/0.5ml Injection Sumatriptan + Naproxen (50mg + 275mg) Tablets (additional strength) 24.11.08 Sumatriptan + Naproxen (50mg + 275mg) Tablets 24.11.08 Sumatriptan 85 mg + Naproxen 500 mg Tablets 3.08.2009 Sumatriptan 85 mg + Naproxen 500 mg Tablets 3.08.2009 Sunitinib malate Capsules 12.5mg/25mg 05-05-2011 (Additional Indication) Sunitinib Maleate Capsules 12.5mg/25mg/50mg 10.04.07 Super Oxidized Solution (containing Water 99.9% with salts like sodium hypochlorite, 12-06-2006 hypochlorous acid, hydrogen peroxide ozone, chlorine chloride, sodium hydroxide, sodium carbonate and sodium chloride) Suramin Injection (For Veterinary) September-1977 Surgical Sealant 26.03.09 Suspension-Each 5ml contains; Trimethoprim-40mg and Sulphamethoxazole-200mg July-1970 Synthetic Diosmin 150mg Tablet & Capsule June-1979 Synthetic Salmon Calcitonin 50IU/100IU/200IU Nasal 18-7-2000 Spray Tablet-Metenolone Acetate- 5mg July-1970 Depot-Metenolone Enanthate-100mg/ml Tacalcitol ointment 4mcg 26.09.11 Tacrine Hcl 10mg/20mg/30mg/40mg Capsule 14-2-1996 Tacrolimus Capsules 0.25mg 3.12.12 Tacrolimus Capsules 0.5mg/1mg/5mg (Additional Indication) 11-08-2011 Tacrolimus Capsules 3mg (Additional Strength) 24-04-2010 Tacrolimus Granules for oral suspension 0.2/1 mg per sachet 26.11.2009 Tacrolimus Ointment 10-03-2003 Tacrolimus PR Caps 0.5/1/5 mg 24-05-2010 TacrolimusCapsule (0.5mg/1mg/5 mg) 21-05-2004 Tadalafil 11-09-2003 Tadalafil Orally Disintegrating Strip 10mg & 20mg (Additional dosage form) 30.07.2014 Tadalafil Tablet 2.5mg/5mg 27.2.13 Tadalafil tablet 20 mg (Additional Indication) 14.11.2009 Tafluprost Eye Drops 0.0015% w/v 21.10.11 Tamoxifen Citrate June-1980 Tamoxifen Citrate 10mg Capsule April-1981 Tamsulosin (0.4mg MR Pellets + Tolterodine 2mg/4mg ER Pellets) Capsules 17.11.08 Tamsulosin + Tolterodine (0.4mg MR Pellets + 2mg/4mg ER Pellets) Capsules 17.11.08 Tamsulosin 0.4mg + Finastride 5mg MR Capsule 17.03.2004 Tamsulosin HCl 04.04.2002 Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet 06.02.2006 Tamsulosin HCl (MR) 0.4mg + Dutasteride 0.5mg tablet 6-2-2006 Tamsulosin Hydrochloride 0.4mg + Tolterodine tartrate 2mg ER capsule 08.10.2008 Tapentadol Extended release tablet 100/150/200mg (Additional strength) 9.12.13 Tapentadol Extended release Tablet 50mg (Additional Strength) 12.11.13 Tapentadol Hydrochloride Tablets 50mg/75mg/100mg 18.04.11 Taurolidine 2.5g + Povidone 6.25g per 500ml 13.01.1994 Taurolidine 2g + Povidone 5g per 100ml 13.01.1994 Tazarotene 12.09.2003 Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) 24.05.2005 Tazarotene (0.05%) + Mometasone Furoate (0.1%) Cream (addl.strength) 24-05-2005 Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream 01-04-2005

PHARMADOCX CONSULTANT 99 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Tazarotene (1mg) +Mometasone Furoate (1mg) per gram cream 04-01-2005 Tegafur (100mg) + Uracil (224mg) capsule. 22-08-2007. Tegafur (100mg) + Uracil (224mg) capsule. 22-08-2007. Tegaserod Maleate 01.11.2002 Teicoplanin 100mg/200mg/400mg per vial i.v/i.m Injection 19-2-1997 Telbivudine 600mg tablet 30-08-06 Telmisartan 25.11.2002 Telmisartan Ph. Eur IP 80mg + Hydrochlorothiazide Ph. Eur 25mg (additional strength) Each 14.05.2013 uncoated bilayered tablet contains: Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength) 15.09.08 Telmisartan + Ramipril (40mg + 2.5mg ) Tablets (Additional Strength) 15.09.08 Telmisartan 20mg + Amlodipine Besylate Eq. to Amlodipine 2.5mg + Hydrochlorothizide 6.25mg 03.01.2013 Tablets (Additional Strength) Telmisartan 20mg + Amlodipine Besylate Eq. to Amlodipine 2.5mg + Hydrochlorothizide 6.25mg 03.01.2013 Tablets (Additional Strength) Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg Tablets 22.05.08 Telmisartan 40 mg + Atorvastatin (as calcium) 10 mg Tablets 22.05.08 Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tablet 05-04-2010 Telmisartan 40/80 mg+ Indapamide SR 1.5/1.5 mg tablet 04-05-2010 Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet 30-08-06 Telmisartan 40mg + Amlodipine (as Besylate) 5mg tablet 30-08-06 Telmisartan 40mg/80mg+ Hydrochlorthiazide 12.5mg/12.5mg tablet 29.08.2003 Telmisartan 80mg + Amlodipine 5mg tablet (Additional strength) 31.03.09 Telmisartan 80mg + Amlodipine 5mg tablet 31.03.09 Telmisartan IP 80mg + Hydrochlorothiazide IP 25mg uncoated bilayered tablet (Additional 14.05.2013 Strength) Telmisartan tablet 20/40/80 mg(Additional indication) 14-05-2010 Temoporfin 1mg/ml Injection (Additional Strength) 08.07.08 Temozolamide 5mg/20mg/100mg/250mg Capsule 17-1-2000 Temozolamide capsules 140mg/180mg (Addl. Strength) 31.03.08 Temozolomide lyophilised powder 100mg / vial 24-05-2010 Temsirolimus Concentrate for Infusion for Injection 25mg/ml 11.12.2010 Teneligliptin Film coated Tablet 20 mg 28.04.2017 Teneligliptin Hydrobromide Hydrate Eq. to Teneligliptin 20mg 05.01.16 Metformin- 500mg/1000mg (ER) Tablets Teneligliptin Tablet 20mg 18.05.2015 Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet 07.01.08 Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet 23-02-2006 Tenofovir Disoproxil Fumarate (300mg) + Emtricitabine (200mg) tablet 23-02-2006 Tenofovir disoproxil fumarate 300mg + Lamivudine 300mg tablet 07.01.08 Tenofovir Disoproxil Fumarate IP 300mg 04.10.2016 Emtricitabine IP 200mg, tablets (additional Indication) Each film coated tablets contains: Tenofovir Disoproxil Fumarate IP 300mg 09.06.2017 Lamivudine IP 300mg Efavirenz IP 400mg (Additional strength) Each Film coated tablet contains: Tenofovir Disoproxil Fumarate Tablet (300mg) 17-08-2005 Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet 08-01-2006 Tenofovir Disoproxil Fumarate300mg + Emtricitabin 200mg + Efavirenz 600mg tablet 1-8-2006 Tenofovir Disoproxil Fumerate 300mg 19.6.2009 Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg FC Tablet 23.07.2008 Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets 23.07.08 Tenofovir Fumarate 300mg + Lamivudine 300mg + Efavirenz 600mg Tablets 23.07.08 Tenoxicam 20mg Dispersible Tablet 31-5-1995 Tenoxicam 20mg Tablet 29-4-1993 Hcl 1mg/2mg/5mg Tablet 27-1-1995 Terbinafine 250mg Tablet Terbinafine 1% Cream 29-3-1995

PHARMADOCX CONSULTANT 100 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Terbutaline Sulphate 0.3mg/ml Syrup November-1979 Terbutaline Sulphate 0.5mg/ml Injection July-1980 Terbutaline sulphate 1.5mg+Guaphenesine 66.5 mg per 5ml syrup Oct-82 Terbutaline Sulphate 10mg/ml Nebulising Solution March-1990 Terbutaline Sulphate 2.5mg/5mg Tablet November-1979 Terconazole 80mg Vaginal Ovule 19-7-1994 Terconazole 0.8% Vaginal Cream Terfenadine 60mg+Pseudoephedrine HCL 120mg as E.R. tablets 24.03.1995 Terfenadine 30mg/60mg/120mg Tablet and Terfenadine 30mg/5ml Suspension September-1990 Teriflunomide 14 mg tablets 13.04.2017 Teriparatide 04-09-2003 Terizidone June-1981 Terlipressin Acetate1mg per vial Injection 22-7-1995 Hcl 5mg Tablet June-1988 Testolactone November-1971 Testolactone 10mg/mL Injection March-1975 Testolactone 50mg Tablet March-1972 Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injection 08.02.07 Testosterone cypionate (100mg/200mg) + Cotton seed oil 736/566mg per ml injection 08.02.07 Testosterone decanoate + Isocaproate Jan-64 Testosterone Gel 1%. 12-07-2005 Testosterone Spray (25mg) 29-11-2005 Testosterone Transdermal Spray (12.5mg/spray) (addl. Lower strength) 15-02-2006 Testosterone Undecanoate 250mg/ml Injection 22.07.08 Testosterone Undecanoate 40mg Capsule September-1985 Tetrabenazine 25mg Tablet 10-3-1999 Tetrachlorodecaoxide 1.037mg/100ml Solution 6-11-1992 Tetracycline HCl 250mg + Broxyquinoline 200mg + Brobenzoxadine 40mg Jan-69 Tetracycline Hcl 250mg Sustained Release Capsule August-1979 Tetrahydro furfuryl salicylate + Ethyl nicotenate + n-Hexyl nicotinate - Ointment July-1963 Tetramisole Hcl 50mg/5ml Syrup December-1976 Tetramisole Hydrochloride May-1970 Tetramisole Hydrochloride 30% (For Veterinary) July-1973 Tetramisole Hydrochloride 50mg/150mg Tablets June-1970 Tetranicotinoyl Fructose November-1971 Tetranicotinoyl Fructose 250mg Tablet December-1971 Thalidomide 12.08.2002 Theophylline 400mg SR + Montelukast10mg Tablet 31.03.09 Theophylline 400mg SR 31.03.09 + Montelukast10mg Tablet Theophylline anhydrous 100mg + Ephedrine HCl 10mg + Diazepam 1mg + Prednisolone 1.5mg Mar-73 tablet Theophylline Ethanoate of Piperazine (0.25gm) Tablet & (0.125gm/ml) Syrup November-1972 Thiabendazole July-1968 Thiamine Propyl Disulphide (Bulk) July-1969 Thiamine Mononitrate IP 10.0mg + Riboflavin IP 10.0mg + Pyridoxine HCl IP 3.0mg + Vit. B12 IP 26.02.2009 15.0mcg + Niacinamide IP 100.0mg + Calcium Pantothenate USP 50mg + Folic Acid IP 1.5mg + Biotin USP 100.0mcg + Ascorbic Acid IP 150.0mg capsule Thiamine Mononitrate IP 10mg + Riboflavin IP 10mg + Pyridoxine HCl IP 3mg + Vit. B12 IP 26.02.2009 15mcg + Niacinamide IP 100mg + Calcium Pantothenate IP 50mg + Folic Acid IP 1.5mg + Biotin USP 100mcg + Ascorbic Acid IP 150mg + Zinc Sulphate monohydrate USP 41.4mg (eq. to 15mg elemental Zinc) capsule Thiethylperazine (10mg) Tablet & (10mg/ml) Ampoule January-1968 Thiethylperazine Dimalate (10.28mg) Tablet & (10.86mg/ml) Ampoule February-1969 Thiocholchicoside SR Tablet 16 mg 31/04/2010 Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets 17.11.08 Thiocolchicoside + Etoricoxib(4mg + 60 mg) FC Tablets 17.11.08

PHARMADOCX CONSULTANT 101 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg +Absolute alchol IP 50mg 11.10.10 per gm gel Thiocolchicoside 0.25% +Methyl salicylate IP 100mg +Menthol IP 50mg +Absolute alchol IP 50mg 11.10.10 per gm gel Thiocolchicoside 4/8mg + Ketoprofen 50/100mg FC Tablet 06.11.2008 Thiocolchicoside 4mg Tablet 25-3-1996 Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets 11.06.08 Thiocolchicoside 4mg/8mg + Ketoprofen 50mg/100mg tablets 11.06.08 Thiocolchicoside 8 mg + Etoricoxib 60 mg tablets (additional strength) 25.04.09 Thiocolchicoside 8 mg 25.04.09 + Etoricoxib 60 mg tablets Thiocolchicoside IP 8/16mg + Lornoxicam 8/16mg (Additional Strength) Each sustained release 08.04.2013 tablet contains: Thiophanate (For Veterinary) December-1973 Thioproperazine 1/5/10/25mg Tablet, 0.75% Ampoule June-1963 Thiotepa Powder for concentrate for solution for infusion 100 mg(Additional strength & indication) 06.04.2017 Thiotepa Powder for concentrate for solution for infusion 15mg (Additional indication) 06.04.2017 Thiothixene 10mg Tablet December-1967 Thymogen Inj. 12.02.2002 Thymosin Alfa-1 Inj 17.01.2001 Tiagabine HCl tablet (2/ 4 /12 /16 mg) 14-05-2004 Tiamulin Hydrogen Fumarate 45% Soluble Granules (For Veterinary) August-1986 Tiamulin hydrogen fumarate solution for injection 162 mg/ml (additional Dosage form) 17.04.15 Tiapride Hydrochloride Tablets 23.06.11 25mg/50mg/100mg Tiaprofenic Acid August-1986 Tiaprofenic Acid 200mg/300mg Tablet December-1986 Tiaprost Trometamol 150mg Injection (For Veterinary) 19-2-1997 Tibolone 2.5mg Tablet 16-10-1996 Ticagrelor 60 mg tablets (Additional strength & indication) 02.05.2017 Ticagrelor Tablet 90mg 03.05.12 Ticarcilin 3gm+ Clavulanic Acid 100mg (per vial) injection 30.10.1996 Ticlopidine 3-3-2000 Ticlopidine Hcl 250mg Tablet 11-2-1993 Tigecycline powder For Inj. 50mg/vial 28-08-06 Tiletamine (as Hydrochloride ) 125 mg/250 mg+ Zolezepam(as hydrochloride ) 125 mg/250 mg 20.01.14 freeze dried powder for injectable(veterinary product) Each freeze-dried vial contains: Tilmicosin 300mg/mL solution for injection (For Veterinary use only) 22-12-2016 Timolol maleate 5mg (as based)+Pilocarpine Hcl 20mg per ml opthalmic solution 25.01.2000 Timolol Maleate 2.5mg/ml & 5mg/ml Ophthalmic Solution July-1985 Timolol Maleate Long Acting Ophthalamic Solution 5mg/ml 14-05-2010 Timolol Maleate SR Eye Drops 5.0mg / ml 08.11.08 Tinazoline Hcl 0.08% Nasal Drops August-1985 Tinidazole 150mg+Diloxonide Furoate 250mg tablet Sep-84 Tinidazole 2mg/ml in 400ml Infusion Bottle & 2mg/ml in 800ml Infusion Bottle (I.V February-1990 Infusion) Tinidazole 150mg Tablet February-1974 Tinidazole 600mg+Norfloxacin 400mg tablets 09.05.1995 Tinidazole 75mg/5ml Suspension December-1983 Tioconazole Vaginal Gel 65mg per gm 22.03.11 Tiotropium (as Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg 31.01.08 + Ciclesomide 400mcg per capsules Tiotropium (as Tiotropium Bromide Monohydrate) 18mcg + Formoterol Fumarate Dihydro. 12mcg 31.01.08 + Ciclesomide 400mcg per capsules Tiotropium Br 9mcg + Femoterol 12mcg Inhaler 26.04.2004 Tiotropium Br 18mcg + Formoterol 12mcg Rotacap 22.04.2004 Tiotropium Bromide 16.04.2003

PHARMADOCX CONSULTANT 102 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Tiotropium Bromide Monohydrate Eq. to Tiotropium 18mcg+Formoterol Fumarate 12mcg dry 22.11.2004 powder inhaler Tiotropium Bromide monohydrate Eq. to Tiotropium 9mcg + Formoterol Fumarate dehydrate eq. to 24.12.2004 Formoterol Fumarate 6mcg meter dose inhaler Tirofiban (0.25mg/ml injection) 09-03-2005 (additional strength) Tirofiban HCl I.V 12.08.2003 Tiropramide Hcl (100mg) tablet 22-08-06 Tizanidine Hcl 2mg/4mg Tablet 22-12-1993 Tizanidine SR 06.02.2002 Tobramycin 10mg/40mg per ml Injection September-1985 Tobramycin Sulphate 0.03% per vial Ophthalmic Solution April-1987 Tobramycin Inhalation solution (300mg/5ml) 22-03-2006 Tobramycin sulphate eq. to Tobramycin 3mg+ Flurometholone 1mg per ml Opthalmic suspension 12.09.2002 Tofisopam uncoated tablet JP... 50/100mg 13-04-2010 Tolfenamic Acid 200mg Capsule 4-3-1998 Tolnaftate (1% Solution in bottle of 10 cc) January-1969 Tolnaytate 10mg + Nystatin 100,000 Units per gm cream Feb-77 Tolperisone HCL 150mg + Paracetamol IP 500mg tablet 21.10.10 Tolperisone Hcl IP 150mg + Diclofenac IP 50mg Tablets 07.12.11 Tolperisone HCL 150mg + Paracetamol IP 500mg tablet 21.10.10 Tolperisone HCl 450mg + Diclofenac Sodium IP 100mg (additional strength) Each sustained 12.04.2013 release tablet contains: Tolperisone HCl 450mg + Diclofenac Sodium IP100mg SR tablets (Additional Strength) 12.04.2013 Tolperisone Hcl IP 150mg + Diclofenac IP 07.12.11 50mg Tablets Tolperisone HCl Mouth Dissolving tablet 50/100 mg (Additional Dosage Form) 04.11.10 Tolperisone Hcl SR 450mg Tablets 30-03-2010 Tolperisone HCl Tablet 50 / 100 / 150mg 26.09.08 Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule. 15-06-2007. Tolterodine Tartrate 4mg (ER) + Tamsulosin HCL 0.4mg Capsule. 15-06-2007. Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet 15.06.07 Tolterodine tartrate ER 4mg + Tamsulocin Hcl. ER 0.4mg tablet 15.06.07 Tolterodine Tartrate Extended release tablets 2mg/4mg (Additional Dosage Form) 31.01.14 Tolterodine-L-Tartrate 13.09.2001 Toltrazuril-2.5gm per 100ml Solution (For Veterinary) 30-4-1998 Tolvaptan Tablets 15/30mg 06.09.2012 Topiramate 25mg/50mg/100mg/200mg/ 300mg/400mg Tablet Topiramate 25mg/50mg Sprinkle 23-8-1999 Capsule Topotecan Hcl 4mg/vial Injection Concentrate 15-6-1999 Topotecan Hydrochloride capsules 0.25/1mg 28-11-2011 (New dosage form) Torsamide 09.06.2003 Torsemide 10mg + Amiloride 5mg tablets 17.01.07 Torsemide 10mg + Amiloride 5mg tablets 17.01.07 Trabectedin powder for Conc. solution for infusion (Additional Indication) 20-03-2010 Trabectedin powder for concentrate for solution for infusion 1 mg/ vial 30.03.09 Tramadol HCl 37.5mg+Paracetamol 325mg tablet 09.01.2003 Tramadol Hcl 50mg/100mg Capsule 27-1-1993 Tramadol Hcl 50mg/ml & 100mg/2ml Injection Tramadol HCL 200mg Controlled Release tablet (Additional Dosage Form) 12.09.13 Tramadol Hcl IP (As Immediate Release Layer) 50mg + Diclofenac Sodium IP (As Sustained 21.11.11 Release Layer) 75mg Tablets Tramadol Hcl IP (As Immediate Release 21.11.11 Layer) 50mg + Diclofenac Sodium IP (As Sustained Release Layer) 75mg Tablets Tramadol SR 27-1-1998

PHARMADOCX CONSULTANT 103 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Trametinib 0.5mg/2mg Tablets (Trametinib Dimethyl Sulfoxide) 18.01.17 Trandalopril 1mg/2mg/4mg/2mg +Verapamil (ER) 240mg/240mg/240mg/180mg tablet 23-11-06 Trandalopril 1mg/2mg/4mg/2mg + Verapamil (ER) 240mg/240mg/240mg/180mg 23-11-06 Trandolapril 03-10-2003 Tranexamic Acid 06.03.2002 Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet 22-02-2005 Tranexamic Acid 25mg/50mg + Ethamsylate 12.5mg/12.5mg Tablet 13.01.2005 Tranexamic Acid (500mg) + Mefenamic acid (250mg) tablet 22-02-2005 Tranexamic Acid 250mg + Ethamsylate 250mg film coated Tablet 29.12.2004 Tranexamic acid Mouth Wash (50mg/ml) 15.6.2007. Tranexamic acid mouthwash (50mg/ml) 15.06.07 Tranexamic Acid Tab SR 750mg 20.02.09 Sulphate 10mg Tablet December-1962 Trapidil 100mg/200mg Capsule Trapidil 11-5-2000 50mg/ml Injection Trastuzumab 440mg/vial Powder Concentrate Infusion 10-7-2000 Travoprost Eye Drops 30mcg/ml with 22.07.2016 polyquaternium-1 10mcg/ml (Additional Strength) Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops 28.01.08 Travoprost 40mcg + Timolol (as Maleate) 5mg per ml of eye drops 28.01.08 Travoprost Eye drops (40mcg/ml) 08-12-2005 Trazadone March-1987 Trazadone 25mg/50mg/100mg Tablet/Capsule July-1987 Tretinion 0.05% Cream July-1974 Tretinion 0.05% Swab July-1974 Tretinoin 0.05%/20gm Vanishing Cream July-1974 Tretinoin 0.05%/50ml Lotion July-1974 Tretinoin Microsphere Gel (0.1% W/V) 26.08.08 Tretinoine Gel as Micro Sphere 0.04% % 0.1% 14.10.08 Triamterene February-1965 Triamterene 50mg + HCTZ 25mg tablet Oct-75 Trichlormethiazide USNF 2mg Tablet December-1978 Triclabendazole 250mg/900mg Bolus (For Veterinary) September-1988 Triclabendazole 5% & 10% w/v Suspension (For Veterinary) September-1988 Triclabendazole 5gm/12gm + Levamisole 3.75gm/7.5gm per 100ml Suspension for Veternary use 01-07-1992 Triclofos December-1964 Triethanalamine Trinitrate Bisphosphate 8mg/16mg Tablets March-1961 Trifluoperazine & Tranylcypromine 1mg/10mg Tablet August-1963 Trifluoperazine Dihydrochloride Capsule February-1967 Trifluperidol Hcl 1mg/ml Injection May-1973 Trifluperidol Hcl 5mg/5ml Oral Liquid May-1973 Trifluperidol Hcl 0.25mg/0.5mg Tablet May-1973 Trifluridine Eye Drops 1% w/v 08.12.11 Triflusal 17.01.2001 Trihexyphenidyl Hcl. Sustained Release Tablet November-1962 Trimebutine Maleate 10-10-2005 Trimetazidine Dihydrochloride 3mg Tablet June-1980 Trimethoprim 80mg + Sulphamethoxazole 400mg per 5ml infusion Oct-76 Trimethoprim & Sulphadoxine Sep-73 Trimethoprim 100mg Tablet June-1983 Trimethoprim 160mg + Sulphamethoxazole 800mg per 3 ml Inj. Jan-79 Trimethoprim 4%w/v + Sulphadoxime 20%w/v Jul-74 Trimethoprim -80mg + Sulmethoxazole - 400 July-1970 Trimethoprim+sulfamoxole Sep-75 Trimethoprin 40mg + sulphamethoxazole 200mg/5ml suspension Jul-70 Trimethoprin 80mg/20mg + sulphamethoxazole 400mg/100mg tablet Jul-70 Trimethoxazine April-1965

PHARMADOCX CONSULTANT 104 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Trimethoxysilyl Quaternary Ammonium Chloride 0.40% hand protectant and sanitizer 11.06.13 Trimethoxysilyl Quaternary Ammonium Chloride solution for spray inanimate surfaces for 16.11.12 disinfection 0.71%. Trimethyl Psoralen April-1965 (as Maleate) 10mg/25mg Tablet January-1969 Trimipramine (10mg/25mg) Tablets & (12.5mg/2ml) Injection September-1968 Tripotassium Dicitrate Bismuth 120mg/5ml Suspension January-1989 Tripotassium Dicitrato Bismuthate March-1989 Tripotassium Dicitrato Bismuthate 120mg Chewable Tablet January-1989 Triptorelin Controlled Release Injection 5-7-1993 Triptorelinembonate equivalent to Triptorelin 10.05.2016 Trithiopara Methoxy Phenyl Propene October-1962 Trithioparamethoxy Phenyl Propene (12.5mg) Tablet May-1969 Trithioparamethoxy Phenyl Propene 12.5mg + Chlopheniramine Maleate 3.0mg Tablet May-1969 Trofosfamide November-1975 Trofosfamide 50mg Tablet August-1976 Trolamine Cream (0.67%) 20-03-2004 Tromantadine Hcl 1gm Ointment 23-2-1995 Tropicamide USP 1% w/v and 0.5% w/v Ophthalmic Solution March-1990 Trospium Chloride ER Capsules 60 mg 04.09.2009 Trospium Chloride film coated tablet 20mg 28.05.09 Troxipide film coated Tablets 50mg /100mg 20-05-2010 Trypsin + Chymotrypsin 10,000 Armour Units per ml Ointment July-1980 Trypsin-Kallikrein Inactivator (5000 k.i.u) Ampoule February-1962 Transdermal Patch 0.5 mg/ 1.0 mg /2.0 mg 24 04 14 Tylosin Tartrate (For Veterinary) May-1980 Tylvalosin tartrate oral soluble granules Sachet 62.5% w/w (Veterinary) 08.10.08 Udenafil Tablet 100mg/200mg 15.09.11 Ulinastatin for Injection 50000 IU / 100000 IU 03.04.12 Ulinastatin Injection 19.09.14 Urea (30%) 300mg/ml Solution for Intra Amniotic Use August-1975 Urokinase for Injection May-1982 Urosulfon April-1965 Ursodeoxycholic Acid (500mg) S.R Tablet 20-07-2005 Ursodeoxycholic Acid 300/600 SR Tablets 08.12.08 (Additional Strength) Ursodeoxycholic acid S.R. Capsule (450mg) 01-12-2004 Ursodeoxycholic Acid Suspension 11.02.11 125mg/5ml and 250 mg /5ml. Ursodeoxycholic acid tablets 600mg 30.01.08 Valacyclovir 25.09.2002 Valdecoxib 01.08.2002 Valdecoxib 20mg + Paracetamol 500mg Tablet 20.09.2004 Valethamate Bromide November-1976 Valganciclovir Powder for Oral Solution 50mg/ml 9.10.2009 Valgancyclovir 20-11-2003 Valsartan 10.12.2001 Valsartan 80mg/160mg/160mg+HCTZ 12.5mg/12.5mg/25mg tablet 18.03.2003 Valsarten 80mg + S(-) Amlodipine (as besylate) 2.5mg capsule 01.11.2003 Vancomycin Hcl 500mg/1000mg per vial Injection 28-3-1994 Vancomycin Hcl 125mg/250mg Capsule Varenicline (As tartrate) 0.5mg/1mg tablets 29.05.07 Vasolastine Ampoule (2ml) January-1961 Vecuronium Bromide Injection June-1986 Velpatasvir Bulk 04.05.2017 Vemurafenib Tablet 240mg 19.10.12

PHARMADOCX CONSULTANT 105 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Venlafaxine Hcl 18-9-2000 25mg/37.5mg/75mg Uncoated Tablet Hcl 6-10-2000 37.5mg/75mg/150mg S.R Capsule Verapamil Hcl. (5 Ampoules of 2.2 ml) July-1967 Vericella Vaccine 19-6-1998 Vernase Tablet November-1967 Vilazodone Hydrochloride 20mg/40mg and Bulk 19.08.15 Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tablets 21.07.08 Vildagliptin 50/50/50mg + Metformin 500/850/1000mg Tablet 21.07.2008 Vildagliptin 50mg/50mg/50mg + Metformin Hcl 500mg +850mg +1000mg tablets 21.07.08 Vildagliptin Tablets 50mg/100mg 18.01.08 Vimpocetine 13.05.2002 Vindesine Sulphate 1mg/5mg per vial Injection 28-10-1998 Vinorelbin Tartrate Inj. 17.01.2001 Vinpocetin 01.08.2003 Virginiamycin obtained from streptomyces virginiae (Veterinary) February-1975 Vit K 1 5mg + Calcium Lactolionate 100 m g+ Carlozocrome Salicylate 2.5mg + Phenol 0.5% Jul-69 + Lignocaine Hcl 1% injection Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. 07-12-2006 Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 23-06-2010 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule

Vitamin A (oily form) as palmiate 2000IU + Vitamin B1 1mg + Vitamin B2 1mg + Vitamin B6 23-06-2010 1.34mg + Vitamin B12 1mcg + Ascorbic acid 33.3mg + Vitamin D3 200IU + Folic acid 0.3mg + Calcium pantothenate 1mg + Niacinamide 15mg + Dibasic calcium phosphate 100mg + Phosphorus 77mg+ Ferrous fumarate 50mg + Copper 0.01mg+ Potassium iodide 0.0015mg + Heavy magnesium oxide 1mg + Manganse sulphate 0.01mg + Potassium sulphate 1mg + Zinc sulphate 0.15mg Capsule

Vitamin A,D & E Jul-69 Vitamin C 500mcg + Zinc Citrate 2.2mg + Selenium 60mcg tablet. 12-7-2006 Vitamin D3 (Cholecalciferol) Orally disintegrating strips 2000 IU 01-10-15 (additional Dosage form) Voglibose 0.3mg + Metformin (SR) 500mg Tablet 08-06-2010 Voglibose (0.2mg/0.3mg) Tablet 17-11-2005 Voglibose 0.2 mg + Metformin 500mg Tablets 13.7.2009 Voglibose 0.2 mg + Metformin 500mg Tablets 13.07.2009 Voglibose 0.2mg/0.3mg tablet (Mouth dissolving) 28.12.07 Voglibose disp.tab.0.2mg/0.3mg 20.11.07 Voglibose IP 0.2mg/0.3mg 14.09.2016 Metformin Hydrochloride IP 1000mg/1000mg, tablet (Additional Strength) Each uncoated tablet contains: Voglibose0.3 +Metformin (SR) 500mg 06-08-10 Voriconazole Powder for oral soluion (40mg/ml) 21-02-2006 Voriconazole Tablet (50 mg/200 mg) Infusion (200 mg/vial) 09-09-2004 VSL # (Combination of lactic acid bacteria (VSL # 3) 31.01.08 VSL # 3 (Probiotic Blend) sachet 31-07-2007. Xanthinol Nicotinate Ampoule February-1967 Xantinol Nicotinate 500mg Sustained Release Tablet February-1973 Xipamide 40mg Tablet July-1980 Hcl 20mg/ml (For Veterinary) November-1990 0.5 mg + Ipratropium 0.6 mg Nasal spray 23.12.2009 Xylometazoline 0.5 mg + Ipratropium 0.6 mg Nasal spray 23.12.2009 Xylometazoline Nasal drops (0.05% & 0.11% ) solution March-1961

PHARMADOCX CONSULTANT 106 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Yeast Tannic Acid Compound October-1971 Yeast tannic acid compound 250mg + lodochlorohydroxyquinoline 150mg + Benzalconium chloride Nov-71 10mg Tablet Yttrium-90 Microspheres Injection (Yttrium-90...3GBq (at the time of calibration) per vial) 3.06.2009 03.12.2001 Zalcitabine 0.375mg/0.750mg Film Coated Tablet 26-7-1993 Zaleplon 17.01.2002 Zaltoprofen film coated tablet 31.10.10 …80mg JP Zanamavir inhalation powder 5mg/blister 13-02-2006 Zanamavir inhalation powder 5mg/blister (Additional Indication) 22.01.08 Zidovudine 600mg ER + Lamivudine 300mg ER 01.03.2004 Zidovudine 300mg Tablet 18-12-1998 Zidovudine Capsule April-1988 uncoated bilayered extended release tablet ...600mg 30.09.10 Zinc (Gluconate) oral solution (20mg/5ml) 05-10-2005 Zinc Glucoheptonate February-1963 Zinc Gluconate 87.1% mg (eq. to elemental Zinc 12.5mg) Ascorbic acid 100mg+ Sodium Ascorbate 12.12.1995 170mg (eq. to 150 mg of Acorbic acid) chewable tablet Zinc Sulphate IP 200mg Capsule September-1978 Ziprasidone HCl 18.03.2002 Ziprasidone powder for injection 03-09-2004 (after reconstitution 20 mg/ml) ZnSO4 0.660mg (heptahydrate eq. to elemental Zinc 0.15mg)+CuSO4 0.236mg (Pentahydrate eq. to 08.10.1994 elmetnal copper 0.06mg)+Chromic chloride 1.83mg (anhydrous eq. to elemental chromium 0.6mg)+MnSO4 0.047mg(monohydrate eq. to elemental maganies 0.025mg+Benzyl alchol 1% (preservative)Trace metal additive infusion (TMA Infusion) Zoalene 25% + Ethoxygim 0.125% premix Jan-75 Zoledronic acid 5mg/100ml solution for infusion (addl. indication). 6-12-2007 Zoledronic Acid Injection 5mg/100ml (Addl. Indication) 07.01.09 Zoledronic Acid Solution for Infusion Addl. Indication 1.08.2009 Zoledronic Tablet 5mg/10mg (additional indication) 27.12.11 Zolendronic Acid 05.11.2001 Zolmitriptan...5.0% 29.05.09 w/v Benzalkonium Chloride NF ... 0.01% w/v Nasal spray Zolpidem Hemitartrate 5mg/10mg Film Coated Tablet 28-5-1999 Zolpidem Tartarate Orally disintegrating Tablet 5mg/10mg 12-10-15 (Additional dosage form) Zolpidem Tartrate E.R tablet (6.25mg/12.5mg). 10-7-2006 Zonisamide (100mg) capsule 21-12-2005 Zonisamide capsule 25/50mg (addl. Strength) 25-05-2006 Zopiclone BP 7.5mg Tablet 16-8-1996 tablet ....25/50/100mg 15-04-2010 Zuclopenthixo Acetate 50mg/200mg per ml Injection Zuclopenthixol 25mg Film Coated Tablet 29-7-1999 α-Ketoisoleucine Calcium salt 67.0mg + α- Ketoleucine Calcium Salt 101.0mg + α- 16.06.2016 Ketophenylalanine Calcium Salt 68.0mg + α- Ketovaline Calcium Salt 86.0mg + α- Hydroxymethionine Calcium Salt 59.0mg + Lycine acetate 105.0mg (=75mg lysine) + Threonine 53.0mg + Tryptophan 23.0mg + Histidine 38.0mg + Tyrosine 30.0mg Film coated tablets β-Carotene (30% dispension) 15mg (eq. to vit. A 7500 I.U)+ Vit. E acetate-25mg+Vit. C- 10.10.2001 100mg+Pyridoxine HCL (Vit. B6) 1.5mg+ Cyanocobalamin (vit. B12) 5mcg+ Folic acid- 400mcg+Zinc as Zno-15mg+Selenium as SeO2 100mg+copper (element) as CuSO4 1mg Capsule β-pyridyl carbinol Tablet July-1964

PHARMADOCX CONSULTANT 107 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

LIST OF CLIENTS API PLANTS SETUP/ FDA MEDICAL GRADE OXYGEN Excellent Pharma Care (India), Sonipat Arun Oxygen Ltd., Yamuna Nagar Glide Chem Pvt. Ltd., Sonipat Air Liquide North (I) Pvt. Ltd., Panipat Kunal Calcium Ltd., Yamuna Nagar Kaveri Industrial Gases, Yamuna Nagar Times Pharma & Chemicals, Gurgaon Laxmi Carbide,

AYURVEDIC PLANT SETUP PHARMA PLANTS SETUP/ FDA Kudos Auurveda Aarge Healthcraft, Parwanoo Daffodil Healthcare, Delhi Alps Life Sciences Pvt. Ltd., Sonipat Hitkary Pharmacy (I) Pvt. Ltd., Sonipat AffyParenterals, Badhi Jagat Pharma, Bareilly Amree Pharmaceuticals, RP Pharmaceuticals, Karnal EmcrossPharmachem, Rookee Banson Pharma, Patiala COSMETICS PLANTS SETUP/ FDA B.V. Bio Corp Pvt. Ltd., Ambala Asmi Int. Pvt. Ltd., Sonipat Clevus Lifesciences, Parwanoo Bionature Personal Care, Panipat Devbhoomi Pharma, Haridwar Bharat Enterprises, Sonipat Dostan Surgical, Ghaziabad Erma Care Pvt. Ltd., Karnal Eshumin BiotechBhatinda, Punjab. Fine & Shine Cosmetics Pvt. Ltd., Sonipat Jackson Labs. Pvt. Ltd., Amritsar Goodrich Agrochem Pvt. Ltd., Karnal Klintoz Pharma Pvt. Ltd., Roorkee IndicaOragnics, Sonipat Magnus Biotech Pvt. Ltd., Karnal Maharishi Herbal Cosmetics, Kundli Mcneil& Argus Pharma Ltd., Ambala MadiaImpex Pvt. Ltd., Panipat Neutec Healthcare Pvt. Ltd. Narela Delhi Omega Remedies Pvt. Ltd., Karnal Opal Healthcare, Pretty Enterprises, Sonipat Pioneer Pharmaceuticals, Vanesa Cosmetics Pvt. Ltd., Sonipat Quest Labs Pvt. Ltd., Indore VNS International, Sonipat Rachil Remedies, PHARMA PLANTS SETUP/ FDA Research Medicine Pvt. Ltd., Sonipat Sceptere Medical India Pvt. Ltd., Sonipat Real Care Lifesciences, Swiss Biotech, Karnal SiaPharma Pvt. Ltd., Sonipat Shreeganesh Biotech, Roorke. Senate Laboratories, Rookee Uttam Lifesciences, Karnal PELLETS Varav Biogenesis Pvt. Ltd., Kalan Biogenetics Pharma, Patiala YaxonBiocare Pvt. Ltd., Sonipat Helpzyn Pharma Kala Amb WHO GMP CERTIFICATION SURGICAL DRESSING PLANT SET UP / FDA

PHARMADOCX CONSULTANT 108 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

Affy Parenteral, Badhi Arya Surgical Industry, Jind Magnus Biotech Pvt. Ltd., Karnal Divine India, Sonipat Mcneil& Argus Pharm. Ltd., Ambala KS Surgical Pvt. Ltd., Modi Nagar Alps Life Sciences Pvt. Ltd., Sonipat M-Pex Surgical Industries, Safidon Klintoz Pharma Pvt. Ltd., Roorkee Sagar Fossil Fuel Pvt Ltd. Systochem Laboratories Ltd., Ghaziabad Glide Chem Pvt. Ltd., Sonipat STERISIATION Solitaire Pharmacia Pvt. Ltd., Chandigarh MicrotrolSterilisation Pvt. Ltd. Rewari for ETO Alligned Industries, Rewari. For GAMMA STER

PHARMADOCX CONSULTANT 109 LIST OF NEW DRUGS 1961 –September 2017 download from http://www.pharmadocx.com/Download

PHARMACEUTICAL STATIONARY We are pleased to offer Pharmaceutical, Cosmetics & Medical Devices Stationary. Various types of registers areneeded for maintaining records as per Schedule M, M-I, M-II, M-III U, U1. We can provide following pre printed registers, duly bound, page numbered, as per Drugs & Cosmetics Rules:-

1. Production Register 2. Raw Material Stock Register (As per Schedule U for Drugs) 3. Raw Material Stock Register (As per Schedule U1 for Cosmetics) 4. Raw Material Sampling Register 5. RLAF Log Book Register 6. Packing Material Stock Register 7. Finished Goods Stock Register 8. Chemical Stock Register 9. Control/ Retain Sample Register 10.Potable/ Purified Water Tank Cleaning Record Register 11. Temperature / Humidity Record Register 12. RM/ PM/FG Entry Register in Lab 13.Daily pH Meter Standardisation Register 14.Equipment operation & cleaning log book Register 15.Building Maintenance Record 16.Service Record of Machine PHARMADOCX (Pharma Consultant) Office. : Opp. Dewan Mill,Old D.C. Road, Sonepat-131001 Ph. 0130-2200630, (M) +91-9896133556 E-mail : [email protected] Web : www.pharmadocx.com

PHARMADOCX CONSULTANT 110