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Noticefdc29may.Pdf Annexure A - May 2019 FDC Identification number as on the website: Version 1 dated 17.05.2019 Format for submission of information on FDC to DTAB Sub-Committee (Submit all the information including full text of references as hard copy as well as soft copy) S. Item Response No. (a) Composition of Product 1a. (FDC): (Details of all ingredients, strengths /dosage forms) (b) Brand name/s if any: (c) Name and Address of the Applicant Whether the applicant is i. Manufacturer: ii. Marketer : iii. Any other (please specify) : iv. -- 1b. Licensing authority with Name and Designation of the licensing Date &Year of year of license and Authority Product License informations, if any submitted to Licensing Authority while obtaining the License 1c. Whether the FDC is approved by DCGI, If so details/evidence thereof 1d. Whether the FDC is Pre 1988, If so details/evidence thereof S. Item Response No. 2. Particulars of the drug: Dosage form, composition of the formulation (including all active ingredients) 3. Indication(s) 4. Provide a copy of the approved Package insert that is currently provided 5. State the category under which FDC approval is claimed as per Drugs and Cosmetics Rules. 6. Pharmacological classification a) Therapeutic justification / rationale for each ingredient 7. and quantity contained in the FDC b) Therapeutic value claimed or purported to be claimed of the FDC (Postulated advantage/ Therapeutic value of FDC)[Tick (√) appropriate option(s)] i. Increased efficacy ii. Reduced incidence of adverse effects iii. Dose reduction iv. Reduced cost v. Booster for another drug vi. Improved patient adherence/ Convenience vii. Minimization of abuse of other actives viii. Reduced development of microbial resistance ix. Any other (please specify) c) Submit a one-page summary with highest level of evidence, supporting the claim of postulated advantage/rationale. The evidence should be enclosed in the form of maximum of five relevant full text articles in peer-reviewed journals/ relevant information from textbooks 8. Pharmacokinetic/ pharmacodynamics rationality with half-life details of individual ingredients, dosage schedule of individual drugs and dosage schedule of FDC (Submit a one-page summary with highest level of evidence, supporting the claim of postulated advantage/rationale. The evidence should be enclosed in the form of maximum of five most relevant full text articles in peer-reviewed journals/ relevant information from textbooks) 2 S. Item Response No. 9. Published data regarding safety and efficacy of FDC (Submit a one-page summary with highest level of evidence, supporting the claim of postulated advantage/rationale. The evidence should be enclosed in the form of maximum of five most relevant full text articles in peer-reviewed journals/ relevant information from textbooks) 10. Safety & Efficacy data if any, regarding the FDC, generated by the applicant (Submit a one-page summary. Also submit the article based on these data, if published or one-page abstract of each study if unpublished with CTRI number if available) 11. Please specify the guidelines National/international/ professional Association/Chapters/bodies) if any, that have recommended the use of the above FDC or use of the ingredients thereof concurrently 12. a) Whether marketed in EU, UK, Canada, Australia, Japan and the USA? b) If yes, which country/countries? c) Specify country-wise product brand name, ingredients, dosage form, its strength, amount of usual ingredients per dosage form, indication/s and dosage frequency 13. Regulatory status of the FDC in other countries 13.1 Countries where the drug is: (a) Marketed (b) Approved (c) Approved as IND (d) withdrawn, if any, with reasons 13.2 Restrictions on use, if any, in countries where marketed/approved 14. Specimen of labels and cartons 15. Any other relevant information 16. Submit one page summary of grounds and reasons in support of FDC with not more than 5 relevant references 17. Submit PPT of presentation in hard copy (Maximum 7 slides) which the company will present to the committee (Note: Individual Form shall be submitted for each FDC and all above information shall be provided for each strength/ dosage in the same Form of FDC) 3 Signature of the Authorized representative: ____________________________________________ Name: ___________________________________________________________________________ Designation: ______________________________________________________________________ Date: _______________________________ Place: _______________________________ For Office Use: Identification No. 4 List of FDCs considered as irrational in 2nd Assessment Report of the Committee FDC Identification Name of the FDC Strength Dosage Form No. CombiKit of 5 tabs. Of Clomiphene Citrate Tablets IP+ 10 2337 50mg, 2mg film coated tabs.Estradiol Valerate Tablet tablets oral 145 Aceclofenac + paracetamol 50 mg+ 125 mg suspension Paracetamol IP+ 432 125mg+50mg Liquids Aceclofenac IP Oral 147 Aceclofenac + Paracetamol 50mg+125mg Suspension Aceclofenac IP+ 50mg/250mg+ 301 Oral Liquid Paracetamol IP 250mg/0.650gm 4343 Aceclofenac IP+ Paracetamol IP 50mg+125mg Suspension Aceclofenac IP+ 224 50mg+125mg Suspension Paracetamol IP Aceclofenac IP+ 305 100mg+250mg/10 ml Oral Liquid Paracetamol IP Aceclofenac IP+ 334 50mg+125mg/5ml Suspension Paracetamol IP Aceclofenac IP+ 336 50mg+125mg Suspension Paracetamol IP Aceclofenac IP+ 619 50mg+125mg Tablet Paracetamol IP 192 Aceclofenac+ paracetamol 50 mg+ 125 mg liquid oral dose 186 Aceclofenac+Paracetamol 50mg+125mg Syrup 392 Aceclofenac+Paracetamol 50mg+125mg Syrup 618 Aceclofenac+Paracetamol IP 50mg+125mg Suspension 2280 Acetylcysteine+Taurine 150mg+500mg Tablets Taurine USP+ 6066 500mg+150mg Oral Tablet Acetylcysteine USP Taurine USP+ Film Coated 6105 500mg+150mg N-Acetylcysteine USP Tablets Adenosine triphosphate diphosphate JPC+ Hard Gelatin 4807 50mg+250mg Magnesium Orotate Capsules 4781 Aloe IP+Vitamin E Acetate IP 4% + 0.50% w/w Soap Aloes IP+Povidone Iodine (0.5% w/w available Iodine) 1156 1.5% w/w + 5%+1% w/w Ointment IP+Metronidazole IP FDC Identification Name of the FDC Strength Dosage Form No. Povidone Iodine IP+ 5%w/w + 1.0%w/w + 1069 Ointment Metronidazole IP+Aloe Vera 1.5%w/w 5.00%w/w + 1.00%w/w + 3813 Povidone Iodine IP+metronidazole IP+ Aloe vera Ointment 1.50%w/w Ambroxol HCl IP+ Terbutaline Sulphate IP+ 30mg+1.25mg+100mg+5 2737 Syrup Ammonium Chloride IP+ Guaiphenesin IP+ 0mg+1.5mg Menthol IP Ambroxol HCl IP+Salbutamol Sulphate IP+ Guaifenesin 15mg+1mg+50mg+ 2936 Syrup IP+ Ammonium Chloride IP+ Menthol IP 100g+1mg Amoxicillin Trihydrate+ 250mg+250mg+ Hard gelatin 956 Dicloxacillin Sodium+ 80 million spores capsules Lactobacillus 20000 DU+50000 HUT+45 AGU+50 endo- Amylase+Protease+Glucoamylase+Pectinase+Alpha PGU+225 GaIU+1000 Galactosidase+Lactase+Beta- ALU+30 BGU+1000 Hard gelatin 4631 Gluconase+Cellulase+Lipase CU+1000 FIP+125000 capsules CR+Bromelain+Xylanase+Hemicellulase+Malt FCCPU+600 XU+400 diastase+Invertase+Papain IP HCU+200 DP0+203 SU+16000 FCCPU Antimony Potassium Tartrate USP+Dried Ferrous ORAL Solid 4745 2.0g+1.26g Sulphate IP dosage form 2.5%w/w+ 0.5%w/w+ 0.5%w/w+ 0.2%w/w+ Azelaic Acid+Tea Tree oil+Salicylic Acid+ Allantoin+Zinc 4012 0.5%w/w+ 0.5%w/w+ External Oxide+ Aloe Vera+ Jojoba oil+ Vitamin-E+ Soap noodles 1.0%w/w+ 0.2%w/w+ 100%w/w 830 Azithromycin IP+Adapalene 2%w/w + 1%w/w gel Beclomethasone Dipropionate IP+Neomycin Sulphate 0.025%w/v + 0.5%w/v + 1782 Ear Drops IP+Clotrimazole IP+Lignocaine HCl IP 1%w/v + 2%w/v Beclomethasone Dipropionate IP+Neomycin Sulphate 0.025%w/v + 0.5%w/v + 1787 Ear Drops IP+Clotrimazole IP+Lignocane HCl IP 1.0%w/v + 2.0%w/v 25 mg+ 140 mg+ benfotiamine + silymarin+ L-ornithine L-aspartate+ film coated 5165 150 mg+ 50 mcg+ sodium selenite + folic acid+ pyridoxine hydrochloride tablet 1 mg+3 mg Benfotiamine+Silymarin+Ornithine L-Asparate+ Selenite+ 25mg+140mg+150mg+ 4744 Tablets Folic Acid+Pyridoxine HCl 50mcg+1mg+3mg 5959 Bismuth Amonium Citrate BP+ Papain IP 50mg+10mg Oral Liquid 1% w/v+ .12 % w/v + 0.05 boric acid + phenylephrine HCL+ naphazoline nitrate+ opthalmic 2419 % w/v +0.005 % + 0.01% menthol + camphor IP-% drops w/v Boric Acid +Phenylephirine IP+Naphazoline Nitrate 1.0% w/v + 0.12% w/v + 2353 Eye Drops IP+Menthol IP+Camphor IP'66' 0.05% w/v + 0.01% w/v Boric Acid IP+ 1.0%w/v + 0.12%w/v + Phenylephirine HCl IP+ 2440 0.05%w/v + 0.005%w/v + Eye Drops Naphazoline Nitrate IP+ Menthol IP+Camphor IP+ 0.01%w/v + 0.02%w/v Benzalkonium Chloride Solution IP FDC Identification Name of the FDC Strength Dosage Form No. Bromhexine HCl IP+ Dextromethorphan Hydrobromide 2552 IP+ 4mg+5mg+50mg Syrup Ammonium Chloride IP 2739 Bromhexine HCl+ Phenylephirine HCl 8mg/8mg+10mg/20mg Tablets 4318 Phenylephrine HCL IP+ Bromhexine HCL IP 5mg+4mg Suspension Phenylephrine hydrochloride+ Bromhexine Hydrochloride Uncoated 4321 10mg+8mg Tablets 3885 Calamine 10% + Aloes 10% +Allantoin 10% + 10% + 0.5% Lotion 8% w/v + 1% w/v + Calamine IP+ Diphenhydramine HCL IP+ Aloe Vera 4790 5% w/v + 6.25% w/v + Lotion Juice+ Glycerine IP+ Camphor BP 0.1% w/v Calamine IP+Diphenhydramine Hydrochloride IP+Alovera 8% w/v + 1% w/v + 4108 Topical Lotion Juice+Camphor BP+Glycerin IP 5% w/v + 6.25% w/v Film Coated 4227 Camylofin dihydrochloride+ Paracetamol IP 25mg+300mg Tablets 63 Camylofin+Paracetamol 25mg+300mg Tablets Cefixime IP eq. to anhydrous Cefixime+ Film Coated 907 200mg+300mg Acetyl Cysteine USP Tablets Cephalexin Monohydrate IP+ 854 1.5gm+10mg Powder Serratiopeptidase 2639 cetirizine + paracetamol + phenylephrine hydrochloride 5 mg + 325 mg + 5 mg
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