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Fdcs Permitted for Continued Manufacturing and Marketing in Respect of the Applicant Under 18 Months Policy Decision (As on 12.07.2018) Sr

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FDCs permitted for continued manufacturing and marketing in respect of the applicant under 18 months policy decision (As on 12.07.2018) Sr. No. Name of FDC Date of NOC 1 Dextromethorphan Hydrobromide IP 10mg+Phenylephirine HCl IP 5mg+Chlorpheniramine Maleate IP 2mg oral solution 16.09.15 2 Pantoprazole Sodium Sesquihydrate IP 40mg+Domperidone IP 10mg capsules 16.07.15 3 Pantoprazole Sodium IP 40mg+Domperidone IP 10mg tablets 16.07.15 4 Nimesulide BP 100mg+Paracetamol IP 325mg uncoated tablets 16.07.15 5 Ferrous Fumarate IP 150mg eq. to elemental Iron 48.75mg+L-Histidine HCl Monohydrate BP 4mg+L-Lysine HCl USP 16.07.15 25mg+Glycine IP 10mg+Riboflavin (Vit. B2) IP 3mg+Thiamine Mononitrate (Vit. B1) IP 5mg+Pyridoxine HCl IP (Vit. B6) 1.5mg+Cyanocobalamin (Vit. B12) IP 2.5mcg+Folic Acid IP 0.5mg capsules 6 Thiamine Mononitrate IP 5mg+Pyridoxine HCl IP 3mg+Cyanocobalamin IP 5mcg tablets 17.07.15 (NOC Withdrawn) 7 Ciprofloxacin 500mg+Tinidazole 600mg tablets 16.07.15 8 Cabonyl Iron 50mg+Folic Acid IP 0.5mg+Zinc Sulphate Monohydrate IP 61.8mg eq. to Zinc 22.5mg hard gelatin capsules 16.07.15 9 Calcium Phospahte 82mg+Vitamin D3 200IU+Vitamin B12 2.5mcg each 5ml suspension 17.07.15 10 Phenylephirine HCl 5mg+Chlorpheniramine Maleate 2mg per ml drops 17.07.15 11 Ferric Ammonium Citrate IP 160mg eq. toelemental Iron 32.8mg+Folic Acid IP 0.5mg+Cyanocobalamin IP 7.5mcg+Manganese 16.07.15 Sulphate IP 30mcg+Cupric Sulphate IP 30mcg per 15ml oral liquid 12 Dried Aluminium Hydroxide Gel IP 300mg+Magnesium Hydroxide Gel IP 250mg+Oxetacaine IP 10mg+Activated Dimethicone 17.07.15 IP 50mg per 5 ml gel 13 Thiamine Hydrochloride IP 2.0mg + Riboflavine Phosphate Sodium IP 2.5mg + Pyridoxine Hydrochloride IP 0.75mg + 17.07.15 Cyanocobalamin IP 2mcg + Niacinamide IP 15mg + Lysine Hydrochloride USP 375mg + D-Panthanol IP 3mg per 5ml syrup 14 Tricholine Citrate 250mg + Thiamine Hydrochloride IP 2.5mg + Riboflavin IP 2.5mg + Pyridoxine Hydrochloride IP 0.75mg + 17.07.15 Cyancocobalamin IP 5mcg per 5ml oral liquid 15 Beclomethasone Dipropionate IP 0.025%w/w+Clotrimazole IP 1.0%w/w cream 17.07.15 16 Ferrous calciu citrate eq. to Iron 50mg+Folic Acid IP 1mg+Zinc (as Zinc sulphate Monohydrate) 12.5mg+Methylcobalamin 15mcg+Manganese (as Manganese sulphate Monohydrate BP) 0.2mg+Copper (as Copper sulphate BP) 0.2mg+selenium (as Sodium selenite pentahydrate BP) 60mcg+Pyridoxine Hydrochloride IP 1.5mg tablet 17 Ferrous Calcium Citrate Eq. to elemental Iron 50mg+Folic Acid IP 0.3mg film coated tablets 17.07.15 18 Ferric Ammonium Citrate IP Eq. to Elemental Iron 50mg + Folic Acid IP 0.5mg + Cyanocobalamin IP 7.5mcg + Zinc Sulphate IP 17.07.15 7.0mg per 15ml syrup 19 Thiamine Hydrochloride IP 1.5mg+Riboflavin Sod. 5 Phosphate IP 1.5mg+Pyridoxine Hydrochloride IP 0.5mg+Cyanocobalamin 17.07.15 IP 2.5mcg+Niacinamide IP 15mg+Lysine Hydrochloride USP 250mg per 5ml syrup 20 Ferric Ammonium Citrate IP 110mg (Eq. to Elemental Iron 22.55mg) + Folic acid IP 1.5mg + Cyanocobalamin IP 15mcg per 5ml 17.07.15 syrup 21 Diphenhydramine HCl IP 14.08mg+Ammonium Chloride IP 138mg+Sodium Citrate IP 57.03mg+Menthol IP 1.14mg per 5ml 17.07.15 syrup 22 Dried Aluminium Hydroxide Gel IP 300mg+Aluminium Magnesium Salicate IP 50mg+Magnesium Hydroxide IP 17.07.15 25mg+Simethicone IP 25mg uncoated chewable tablets 23 Oral liquid of Chlorpheniramine Maleate IP 3mg+Ammonium Chloride IP 130mg+Sodium Citrate IP 65mg+Menthol IP 0.5mg 17.07.15 (Already per 5ml syrup Prohibited) 24 1.25g Calcium Carbonate from an organic Source (Oyster Shell) Eq. to elemental Calcium 500mg + Vitamin D3 IP 250IU film 17.07.15 coated tablets 25 Nimesulide BP 100mg+Paracetamol IP 325mg tablets 17.07.15 26 Thiamine HCl IP 1.5mg+Riboflavin IP 1.5mg+Pyridoxine HCl IP 0.5mg+Niacinamide IP 15mg+Cyanocobalamin IP 16.07.15 2.5mcg+Lysine HCl USP 250mg+Choline Dihydrogen Citrate USNF 30mg per 5ml syrup 27 Thiamine HCL IP 1.5mg+Riboflavin IP 1.5mg+Pyridoxine HCl IP 0.5mg+Niacinamide IP 15mg+Cyanocobalamin IP 17.07.15 2.5mcg+Vitamin A IP 1000IU+Choline Dihydrogen Citrate USNF 20mg+Colecalciferol IP 200IU+Calcium Gluconate IP 170mg per 5ml syrup 28 Beclomethasone Dipropionate IP 0.025%w/w+Clotrimazole IP 1.0%w/w cream 17.07.15 29 Ciprofloxacin HCl IP eq. to Ciprofloxacin 500mg+Tinidazole IP 600mg film coated tablets 17.07.15 30 Ambroxol Hydrochloride IP 15mg+Ammonium chloride IP 60mg+Guaiphenesin IP 50mg+Menthol IP 1mg oral liquid 28.09.15 31 Levosalbutamol sulphate IP eq. To Levosalbutamol 0.5mg+Ambroxol Hydrochloride IP 15mg+Guiaphenesin IP 50mg per 5ml 17.07.15 syrup (for symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis) 32 Prednisolone Acetate IP 0.5%w/v+Chloramphenicol IP 5%w/v+Acetic acid IP 2%w/v+Benzocaine IP 3%w/v ear drops 17.07.15 33 Potassium Iodide IP 3.3%w/v+Calcium Chloride 2H2O IP 1.33%w/v+Sodium chloride IP 0.83%w/v+Sodium methyl hydroxy 17.07.15 benzoate IP eqvi. to methyl hydroxy benzoate 0.023%w/v+ Sodium propyl hydroxy benzoate IP eqvi. to propyl hydroxy benzoate 0.011%w/v eye drops 34 Phenylephrine Hydrochloride IP 5%w/v+Tropicamide IP 0.8%w/v+Benzalkonium Chloride solution IP 0.01% eye drops 17.07.15 35 Chlordiazepoxide 5mg+Clidinium Bromide 2.50mg+Dicyclomine 10mg film coated tablets 17.07.15 36 Calcium Carbonate IP 1250mg+Alfacalcidol 0.25mcg film coated tablets 17.07.15 37 Calcium Citrate USP 1000mg+Vitamin D3 IP 200IU+Methylcobalamin 500mcg+Pyridoxine HCl IP 10mg+Folic Acid IP 5mg 17.07.15 tablets 38 Dicyclomine Hcl IP 10mg+Activated Dimethicone IP 40mg per ml drops 17.07.15 39 Nimesulide 100mg+Paracetamol 325mg tablets 17.07.15 40 Metformin Hydrochloride IP 500mg + Gliclazide IP 80mg uncoated tablet 17.07.15 41 Coenzyme Q10 300mg+Astaxanthin 8mg tablets 17.07.15 42 Sucralfate USP 1gm + Oxetacaine BP 10mg per 5ml suspension 17.07.15 43 Azelastine HCl BP 0.14%w/v + Fluticasone Propionate IP 0.05%w/v nasal spray 17.07.15 44 Thiamine HCl IP 2.5mg+Riboflavin IP 2.5mg+Pyridoxine HCl IP 0.5mg+Niacinamide IP 25mg+Cyanocobalamin IP 3mcg+D- 17.07.15 Panthenol IP 10mg+Zinc Sulphate 20mg eq. to elemental zinc 4.55mg per5ml oral liquid 45 Protein Hydrolysate liquid 20% 1gm+Folic acid 1mg+Ferric Ammonium Citrate 150mg+L-Lysine HCl 50mg+Cyanocobalamin 17.07.15 7.5mcg+Niacinamide 45mg+zinc Sulphate 44mg+Pyridoxine Hcl 1.5mg per 15ml syrup 46 Ferrous Calcium Citrate Eq. to Iron 25mg + Folic Acid IP 0.3mg film coated tablets 17.07.15 47 Ferrous calciu citrate eq. to Iron 50mg+Folic Acid IP 1mg+Zinc (as Zinc sulphate Monohydrate) 12.5mg+Methylcobalamin 17.07.15 15mcg+Manganese (as Manganese sulphate Monohydrate BP) 0.2mg+Copper (as Copper sulphate BP) 0.2mg+selenium (as Sodium selenite pentahydrate BP) 60mcg+Pyridoxine Hydrochloride IP 1.5mg 48 Ferrous Calcium citrate eq. to Iron 25mg+ Folic acid 0.3mg tablets 17.07.15 49 Dextromethorphan Hydrobromide IP 10mg+Chlorpheniramine Maleate IP 2mg+Phenylephirine HCl IP 5mg per 5ml syrup 16.09.15 50 Chlorpheniramine Maleate 2mg+Phenylephirine HCl 5mg syrup 28.09.15 51 Diclofenac Diethylamine BP 17.4mg+Methyl Salicylate IP 100mg+Menthol IP 50mg+Camphor IP 10mg per ml liniment 16.07.15 52 Diclofenac Diethylamine BP 17.4mg+Capsaicin Powder USP 0.2mg+Menthol IP 100mg+Camphor IP 10mg per ml liniment 17.07.15 53 Chlorhexidine Gluconate 1%w/w+Metronidazole 1%w/w+Lignocaine 2%w/w gel 17.07.15 54 Folic acid 5mg+Ferrous Ascorbate Eq. to Elemental Iron 100mg+Methylcobalamin JP 500mcg+zinc Picolinate 15mg film coated 17.07.15 tablet 55 Diclofenac Diethylamine BP 1.16%w/w eq. to Diclofenac Sodium 1%w/w+Methyl Salicylate IP 10%w/w+Menthol IP 17.07.15 5%w/w+Linseed oil BP 3%w/w+Capsaicin USP 0.025%w/w+Benzyl Alcohol IP 1%w/w gel 56 Methylcobalamin 500mcg+Vitamin D3 IP 200IU+Calcium Citrate USP 1000mg+Pyridoxine HCl IP 10mg+Folic Acid IP 5mg 17.07.15 film coated tablets 57 Cefixime (as Trihydrate) IP Eq. to anhydrous Cefixime 50mg + Ofloxacin IP 50mg per 5ml of reconstituted suspension 17.07.15 58 Calcium Carbonate eq. to elemental Calcium 500mg+Calcitriol IP 0.25mcg+Vitamin K27 100mcg film coated tablets 17.07.15 59 Methylcobalamin JP 1500mcg+Alpha Liopic Acid IP 100mg+Pregabalin IP 75mg+Pyridoxine HCl IP 3mg film coated tablets 17.07.15 60 Chlorpheniramine Maleate IP 2mg+Phenylephirine HCl IP 5mg per 5ml syrup 17.07.15 61 Methylcobalamin JP 750mcg+Alpha Liopic Acid USP 100mg+Gabepentin USP 300mg+Pyridoxine HCl IP 3mg tablets 17.07.15 62 Methylcobalamin JP 1500mcg+Docosahexanoic acid 10% 200mg+Folic acid IP 1.5mg tablets 17.07.15 63 Chlorpheniramine Maleate IP 2mg+Phenylephrine HCL IP 5mg per 5ml syrup 17.07.15 64 Dextromethorphan Hydrobromide IP 15mg + Phenylephrine Hydrochloride IP 5mg + Chlorpheniramine Maleate IP 2mg per 5ml 16.09.15 syrup 65 Zinc Sulphate Monohydrate USP 61.8mg eq. To 22.5mg elemental zinc+Thiamine Mononitrate IP 10mg+Riboflavin IP 17.07.15 10mg+Niacinamide IP 50mg+Pyridoxine HCl IP 2mg+cyanocobalamin IP 7.5mcg+Calcium Pantothenate IP 25mg+Tocopheryl Acetate IP 20mg+Ascorbic Acid IP 150mg capsules 66 Dextromethorphan Hydrobromide IP 5mg+Phenylephrine Hydrochloride IP 2.5mg+Chlorpheniramine Maleate IP 1mg per 5ml 16.09.15 syrup 67 Dextromethorphan Hydrobromide IP 10mg+Phenylephrine Hydrochloride IP 5mg+Chlorpheniramine Maleate IP 2mg per 5ml 16.09.15 syrup 68 Potassium Nitrate BP 5.0%w/w+Sodium Monofluorophosphate USP 0.7%w/w tooth gel 16.09.15 69 Glycerin IP 11.25%w/w+Methy Paraben IP 0.1%w/w+Propyl Paraben IP0.04%w/w gel 16.09.15 70 Urea IP 10.0%w/w+Lactic Acid 10.0%w/w+Light Liquid Paraffin 10.0%w/w+Propylene Glycol 10.0%w/w+Mehtyl Paraben 16.09.15 0.16%w/w+Propyl paraben 0.04%w/w cream 71 Clobetasol Propionate 0.05%w/w+Salicylic Acid 3%w/w ointment 16.07.15 72 Choline salicylate 8.7%w/w+Lignocaine HCl 2.0%w/w+Benzalkonium Chloride 0.01%w/w gel 17.07.15 73 Diclofenac Diethylamine 1.16%w/w Eq.
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    Supplementary Information

    Supplementary Information Network-based Drug Repurposing for Novel Coronavirus 2019-nCoV Yadi Zhou1,#, Yuan Hou1,#, Jiayu Shen1, Yin Huang1, William Martin1, Feixiong Cheng1-3,* 1Genomic Medicine Institute, Lerner Research Institute, Cleveland Clinic, Cleveland, OH 44195, USA 2Department of Molecular Medicine, Cleveland Clinic Lerner College of Medicine, Case Western Reserve University, Cleveland, OH 44195, USA 3Case Comprehensive Cancer Center, Case Western Reserve University School of Medicine, Cleveland, OH 44106, USA #Equal contribution *Correspondence to: Feixiong Cheng, PhD Lerner Research Institute Cleveland Clinic Tel: +1-216-444-7654; Fax: +1-216-636-0009 Email: [email protected] Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. Supplementary Table S2. Protein sequence identities across 5 protein regions in 15 coronaviruses. Supplementary Table S3. HCoV-associated host proteins with references. Supplementary Table S4. Repurposable drugs predicted by network-based approaches. Supplementary Table S5. Network proximity results for 2,938 drugs against pan-human coronavirus (CoV) and individual CoVs. Supplementary Table S6. Network-predicted drug combinations for all the drug pairs from the top 16 high-confidence repurposable drugs. 1 Supplementary Table S1. Genome information of 15 coronaviruses used for phylogenetic analyses. GenBank ID Coronavirus Identity % Host Location discovered MN908947 2019-nCoV[Wuhan-Hu-1] 100 Human China MN938384 2019-nCoV[HKU-SZ-002a] 99.99 Human China MN975262
  • PMBJP Product.Pdf

    PMBJP Product.Pdf

    Sr. Drug Generic Name of the Medicine Unit Size MRP Therapeutic Category No. Code Analgesic & Antipyretic / Muscle 1 1 Aceclofenac 100mg and Paracetamol 325 mg Tablet 10's 10's 8.00 relaxants Analgesic & Antipyretic / Muscle 2 2 Aceclofenac Tablets IP 100mg 10's 10's 4.37 relaxants Acetaminophen 325 + Tramadol Hydrochloride 37.5 film Analgesic & Antipyretic / Muscle 3 4 10's 8.00 coated Tablet 10's relaxants Analgesic & Antipyretic / Muscle 4 5 ASPIRIN Tablets IP 150 mg 14's 14's 2.70 relaxants DICLOFENAC 50 mg+ PARACETAMOL 325 mg+ Analgesic & Antipyretic / Muscle 5 6 10's 11.30 CHLORZOXAZONE 500 mg Tablets 10's relaxants Diclofenac Sodium 50mg + Serratiopeptidase 10mg Tablet Analgesic & Antipyretic / Muscle 6 8 10's 12.00 10's relaxants Analgesic & Antipyretic / Muscle 7 9 Diclofenac Sodium (SR) 100 mg Tablet 10's 10's 6.12 relaxants Analgesic & Antipyretic / Muscle 8 10 Diclofenac Sodium 25mg per ml Inj. IP 3 ml 3 ml 2.00 relaxants Analgesic & Antipyretic / Muscle 9 11 Diclofenac Sodium 50 mg Tablet 10's 10's 2.90 relaxants Analgesic & Antipyretic / Muscle 10 12 Etoricoxilb Tablets IP 120mg 10's 10's 33.00 relaxants Analgesic & Antipyretic / Muscle 11 13 Etoricoxilb Tablets IP 90mg 10's 10's 25.00 relaxants Analgesic & Antipyretic / Muscle 12 14 Ibuprofen 400 mg + Paracetamol 325 mg Tablet 10's 15's 5.50 relaxants Analgesic & Antipyretic / Muscle 13 15 Ibuprofen 200 mg film coated Tablet 10's 10's 1.80 relaxants Analgesic & Antipyretic / Muscle 14 16 Ibuprofen 400 mg film coated Tablet 10's 15's 3.50 relaxants Analgesic & Antipyretic
  • )&F1y3x PHARMACEUTICAL APPENDIX to THE

    )&F1y3x PHARMACEUTICAL APPENDIX to THE

    )&f1y3X PHARMACEUTICAL APPENDIX TO THE HARMONIZED TARIFF SCHEDULE )&f1y3X PHARMACEUTICAL APPENDIX TO THE TARIFF SCHEDULE 3 Table 1. This table enumerates products described by International Non-proprietary Names (INN) which shall be entered free of duty under general note 13 to the tariff schedule. The Chemical Abstracts Service (CAS) registry numbers also set forth in this table are included to assist in the identification of the products concerned. For purposes of the tariff schedule, any references to a product enumerated in this table includes such product by whatever name known. Product CAS No. Product CAS No. ABAMECTIN 65195-55-3 ACTODIGIN 36983-69-4 ABANOQUIL 90402-40-7 ADAFENOXATE 82168-26-1 ABCIXIMAB 143653-53-6 ADAMEXINE 54785-02-3 ABECARNIL 111841-85-1 ADAPALENE 106685-40-9 ABITESARTAN 137882-98-5 ADAPROLOL 101479-70-3 ABLUKAST 96566-25-5 ADATANSERIN 127266-56-2 ABUNIDAZOLE 91017-58-2 ADEFOVIR 106941-25-7 ACADESINE 2627-69-2 ADELMIDROL 1675-66-7 ACAMPROSATE 77337-76-9 ADEMETIONINE 17176-17-9 ACAPRAZINE 55485-20-6 ADENOSINE PHOSPHATE 61-19-8 ACARBOSE 56180-94-0 ADIBENDAN 100510-33-6 ACEBROCHOL 514-50-1 ADICILLIN 525-94-0 ACEBURIC ACID 26976-72-7 ADIMOLOL 78459-19-5 ACEBUTOLOL 37517-30-9 ADINAZOLAM 37115-32-5 ACECAINIDE 32795-44-1 ADIPHENINE 64-95-9 ACECARBROMAL 77-66-7 ADIPIODONE 606-17-7 ACECLIDINE 827-61-2 ADITEREN 56066-19-4 ACECLOFENAC 89796-99-6 ADITOPRIM 56066-63-8 ACEDAPSONE 77-46-3 ADOSOPINE 88124-26-9 ACEDIASULFONE SODIUM 127-60-6 ADOZELESIN 110314-48-2 ACEDOBEN 556-08-1 ADRAFINIL 63547-13-7 ACEFLURANOL 80595-73-9 ADRENALONE
  • Novel and Effective Almagate Enema for Hemorrhagic Chronic Radiation Proctitis and Its Risk Factors

    Novel and Effective Almagate Enema for Hemorrhagic Chronic Radiation Proctitis and Its Risk Factors

    DOI:http://dx.doi.org/10.7314/APJCP.2016.17.2.631 Novel and Effective Almagate Enema for Hemorrhagic Chronic Radiation Proctitis and its Risk Factors RESEARCH ARTICLE Novel and Effective Almagate Enema for Hemorrhagic Chronic Radiation Proctitis and Risk Factors for Fistula Development Zi-Xu Yuan1,2,3&, Teng-Hui Ma1&, Qing-Hua Zhong1, Huai-Ming Wang1, Xi-Hu Yu 1,3, Qi-Yuan Qin1, Li-Li Chu1, Lei Wang1,3*, Jian-Ping Wang1,3* Abstract Radiation proctitis is a common complication after radiotherapy for pelvic malignant tumors. This study was conducted to assess the efficacy of novel almagate enemas in hemorrhagic chronic radiation proctitis (CRP) and evaluate risk factors related to rectal deep ulcer or fistula secondary to CRP. All patients underwent a colonoscopy to confirm the diagnosis of CRP and symptoms were graded. Typical endoscopic and pathological images, risk factors, and quality of life were also recorded. A total of 59 patients were enrolled. Gynecological cancers composed 93.1% of the primary malignancies. Complete or obvious reduction of bleeding was observed in 90% (53/59) patients after almagate enema. The mean score of bleeding improved from 2.17 to 0.83 (P<0.001) after the enemas. The mean response time was 12 days. No adverse effects were found. Moreover, long-term successful rate in controlling bleeding was 69% and the quality of life was dramatically improved (P=0.001). The efficacy was equivalent to rectal sucralfate, but the almagate with its antacid properties acted more rapidly than sucralfate. Furthermore, we firstly found that moderate to severe anemia was the risk factor of CRP patients who developed rectal deep ulcer or fistulas P( = 0.015).