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List of Fdcs (Under Category 'C') Permitted for Continued Manufacturing and Marketing Under 18 Month Policy Decision

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List of Fdcs (Under Category 'C') Permitted for Continued Manufacturing and Marketing Under 18 Month Policy Decision List of FDCs (under category 'c') permitted for continued manufacturing and marketing under 18 month policy decision S. No. Name of FDC Date of NOC 1 Pantoprazole Sodium Sesquihydrate IP 40mg+Domperidone IP 10mg capsules 16.07.15 Ferrous Fumarate IP 150mg eq. to elemental Iron 48.75mg+L-Histidine HCl Monohydrate BP 4mg+L-Lysine HCl USP 2 25mg+Glycine IP 10mg+Riboflavin (Vit. B2) IP 3mg+Thiamine Mononitrate (Vit. B1) IP 5mg+Pyridoxine HCl IP (Vit. 16.07.15 B6) 1.5mg+Cyanocobalamin (Vit. B12) IP 2.5mcg+Folic Acid IP 0.5mg capsules 3 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 4 Calcium Phosphate eq. to Elemental Calcium 82mg+Vitamin D3 200IU+Vitamin B12 2.5mcg each 5ml suspension 17.07.15 Ferric Ammonium Citrate IP 160mg eq. to elemental Iron 32.8mg+Folic Acid IP 0.5mg+Cyanocobalamin IP 5 16.07.15 7.5mcg+Manganese Sulphate IP 30mcg+Cupric Sulphate IP 30mcg per 15ml oral liquid Dried Aluminium Hydroxide Gel IP 300mg+Magnesium Hydroxide Gel IP 250mg+Oxetacaine IP 10mg+Activated 6 17.07.15 Dimethicone IP 50mg per 5 ml gel Thiamine Hydrochloride IP 2.0mg + Riboflavine Phosphate Sodium IP 2.5mg + Pyridoxine Hydrochloride IP 0.75mg + 7 Cyanocobalamin IP 2mcg + Niacinamide IP 15mg + Lysine Hydrochloride USP 375mg + D-Panthanol IP 3mg per 5ml 17.07.15 syrup Tricholine Citrate 250mg + Thiamine Hydrochloride IP 2.5mg + Riboflavin IP 2.5mg + Pyridoxine Hydrochloride IP 8 17.07.15 0.75mg + Cyanocobalamin IP 5mcg per 5ml oral liquid Ferrous calcium citrate eq. to Iron 50mg+Folic Acid IP 1mg+Zinc (as Zinc sulphate Monohydrate) 9 12.5mg+Methylcobalamin 15mcg+Manganese (as Manganese sulphate Monohydrate BP) 0.2mg+Copper (as Copper July 2015 sulphate BP) 0.2mg+Selenium (as sodium selenite pentahydrate BP) 60mcg+Pyridoxine Hydrochloride IP 1.5mg tablet 10 Ferrous Calcium Citrate Eq. to elemental Iron 50mg+Folic Acid IP 0.3mg film coated tablets 17.07.15 Ferric Ammonium Citrate IP Eq. to Elemental Iron 50mg + Folic Acid IP 0.5mg + Cyanocobalamin IP 7.5mcg + Zinc 11 17.07.15 Sulphate IP 7.0mg per 15ml syrup Thiamine Hydrochloride IP 1.5mg+Riboflavin Sod. 5 Phosphate IP 1.5mg+Pyridoxine Hydrochloride IP 12 17.07.15 0.5mg+Cyanocobalamin IP 2.5mcg+Niacinamide IP 15mg+Lysine Hydrochloride USP 250mg per 5ml syrup Dried Aluminium Hydroxide Gel IP 300mg+Aluminium Magnesium Salicate IP 50mg+Magnesium Hydroxide IP 13 17.07.15 25mg+Simethicone IP 25mg uncoated chewable tablets 1.25g Calcium Carbonate from an organic Source (Oyster Shell) Eq. to elemental Calcium 500mg + Vitamin D3 IP 250IU 14 17.07.15 film coated tablets Thiamine HCl IP 1.5mg+Riboflavin IP 1.5mg+Pyridoxine HCl IP 0.5mg+Niacinamide IP 15mg+Cyanocobalamin IP 15 2.5mcg+Vitamin A IP 1000IU+Choline Dihydrogen Citrate USNF 20mg+Cholecalciferol IP 200IU+Calcium Gluconate 17.07.15 IP 170mg per 5ml syrup 16 Ambroxol Hydrochloride IP 15mg+Ammonium chloride IP 60mg+Guaiphenesin IP 50mg+Menthol IP 1mg oral liquid 28.09.15 Levosalbutamol sulphate IP eq. To Levosalbutamol 0.5mg+Ambroxol Hydrochloride IP 15mg+Guaiphenesin IP 50mg per 17 5ml syrup (for symptomatic relief of bronchospasm in bronchial asthma and chronic bronchitis) 17.07.15 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 18 17.07.15 Potassium Iodide IP 3.3%w/v+Calcium Chloride 2H2O IP 1.33%w/v+Sodium chloride IP 0.83%w/v+Sodium methyl 19 hydroxy benzoate IP eqvi. to methyl hydroxy benzoate 0.023%w/v+ Sodium propyl hydroxy benzoate IP eqvi. to propyl 17.07.15 hydroxy benzoate 0.011%w/v eye drops 20 Phenylephrine Hydrochloride IP 5%w/v+Tropicamide IP 0.8%w/v+Benzalkonium Chloride solution IP 0.01% eye drops 17.07.15 21 Chlordiazepoxide 5mg+Clidinium Bromide 2.50mg+Dicyclomine 10mg film coated tablets 17.07.15 Calcium Citrate USP 1000mg+Vitamin D3 IP 200IU+Methylcobalamin 500mcg+Pyridoxine HCl IP 10mg+Folic Acid IP 22 17.07.15 5mg tablets 23 Coenzyme Q10 300mg+Astaxanthin 8mg tablets 17.07.15 24 Azelastine HCl BP 0.14%w/v + Fluticasone Propionate IP 0.05%w/v nasal spray 17.07.15 Thiamine HCl IP 2.5mg+Riboflavin IP 2.5mg+Pyridoxine HCl IP 0.5mg+Niacinamide IP 25mg+Cyanocobalamin IP 25 17.07.15 3mcg+D-Panthenol IP 10mg+Zinc Sulphate 20mg eq. to elemental Zinc 4.55mg per 5ml oral liquid Protein Hydrolysate liquid 20% 1gm+Folic acid 1mg+Ferric Ammonium Citrate 150mg+L-Lysine HCl 26 17.07.15 50mg+Cyanocobalamin 7.5mcg+Niacinamide 45mg+zinc Sulphate 44mg+Pyridoxine Hcl 1.5mg per 15ml syrup 27 Ferrous Calcium citrate eq. to Iron 25mg+ Folic acid 0.3mg tablets 17.07.15 28 Chlorpheniramine Maleate 2mg+Phenylephirine HCl 5mg per 5 ml syrup 28.09.15 29 Diclofenac Diethylamine BP 17.4mg+Methyl Salicylate IP 100mg+Menthol IP 50mg+Camphor IP 10mg per ml liniment 16.07.15 Diclofenac Diethylamine BP 17.4mg+Capsaicin Powder USP 0.2mg+Menthol IP 100mg+Camphor IP 10mg per ml 30 17.07.15 liniment Folic acid 5mg+Ferrous Ascorbate Eq. to Elemental Iron 100mg+Methylcobalamin JP 500mcg+zinc Picolinate 15mg film 31 17.07.15 coated tablet Methylcobalamin 500mcg+Vitamin D3 IP 200IU+Calcium Citrate USP 1000mg+Pyridoxine HCl IP 10mg+Folic Acid IP 32 17.07.15 5mg film coated tablets 33 Cefixime (as Trihydrate) IP Eq. to anhydrous Cefixime 50mg + Ofloxacin IP 50mg per 5ml of reconstituted suspension 17.07.15 34 Calcium Carbonate eq. to elemental Calcium 500mg+Calcitriol IP 0.25mcg+Vitamin K27 100mcg film coated tablets 17.07.15 Methylcobalamin JP 1500mcg+Alpha Liopic Acid IP 100mg+Pregabalin IP 75mg+Pyridoxine HCl IP 3mg film coated 35 17.07.15 tablets 36 Methylcobalamin JP 750mcg+Alpha Liopic Acid USP 100mg+Gabepentin USP 300mg+Pyridoxine HCl IP 3mg tablets 17.07.15 37 Methylcobalamin JP 1500mcg+Docosahexanoic acid 10% 200mg+Folic acid IP 1.5mg tablets 17.07.15 Zinc Sulphate Monohydrate USP 61.8mg eq. To 22.5mg elemental zinc+Thiamine Mononitrate IP 10mg+Riboflavin IP 38 10mg+Niacinamide IP 50mg+Pyridoxine HCl IP 2mg+cyanocobalamin IP 7.5mcg+Calcium Pantothenate IP 17.07.15 25mg+Tocopheryl Acetate IP 20mg+Ascorbic Acid IP 150mg capsules 39 Potassium Nitrate BP 5.0%w/w+Sodium Monofluorophosphate USP 0.7%w/w tooth gel 16.09.15 40 Glycerin IP 11.25%w/w+Methy Paraben IP 0.1%w/w+Propyl Paraben IP 0.04%w/w gel 16.09.15 41 Clobetasol Propionate 0.05%w/w+Salicylic Acid 3%w/w ointment 16.07.15 42 Ferrous Ascorbate Eq. to elemental Iron 100mg+Folic acid IP 1.5mg+Methylcobalamin JP 1500mcg film coated tablet 17.07.15 43 Calcium Carbonate 625mg eq. to elemental calcium 250mg+Vitamin D3 125 IU per 5ml oral suspension 17.07.15 Ferrous Ascorbate Eq. to Elemental Iron 100mg+Zinc Bisglycinate 91.3mg Eq. to elemental Zinc 27.5mg+Folic acid IP 44 17.07.15 500mcg+Adenoxylcobalamine 500mcg film coated tablets 45 Albendazole IP 400mg+Ivermectin IP 12mg uncoated chewable tablets 28.09.15 Diclofenac Diethylamine BP 1.16%w/w (Eq. to Diclofenac Sodium 1%w/w) + Olenium lini 3%w/w (Containing 46 Predominantly Linolenic Acid) + Methyl Salicylate IP 10%w/w + Menthol IP 5%w/w + Benzyl Alcohol IP 1%w/w 17.07.15 myofenac gel Dried Aluminium hydroxide Gel IP 250mg+Magnesium Hydroxide IP 250mg+Simethicone IP 50mg per 5ml oral 47 17.07.15 suspension Ferrous Glycine Sulphate eq. to elemental Iron 50mg+Folic Acid IP 0.5mg+Cyanocobalamin IP 7.5mcg+Zinc Sulphate 48 17.07.15 Monohydrate IP eq. to Zinc 2.5mg+D-Biotin BP 100mcg per 15ml suspension Polymixin B Sulphate BP 5000 Units + Chloramphenicol IP 4mg + Dexamethasone Sodium Phosphate IP 1mg + Phenyl 49 16.09.15 mercuric Nitrate IP (As preservative) 0.001%w/v eye/ear drops 50 Ofloxacin 0.3%w/v+Dexamethasone sodium phosphate 0.1%w/v+Benzalkonium chloride 0.01%w/v eye/ear drops 17.07.15 Polymyxin B sulphate BP 5000IU+Chloramphenicol IP 4mg+Phenyl mercuric Nitrate IP (As preservative) 0.001%w/w 51 17.07.15 eye/ear drops 52 Polyvinyl Alcohol 1.4%w/v+Povidone 0.6%w/v+Benzalkonium Chloride solution 0.01%w/v eye drops 17.07.15 Ferrous Fumarate 300mg+Folic Acid 0.75mg+Pyridoxine HCl 1.5mg+Cyanocobalamin IP 7.5mcg+Zinc Sulphate IP 53 17.07.15 7.5mg capsules Phenylephrine HCl IP 5mg+Chlorpheniramine Maleate IP 1mg+Sodium Citrate IP 60mg+Menthol IP 1mg per 5ml oral 54 16.07.15 syrup 55 Methylcobalamin JP 500mcg+Thiamine Mononitrate 10mg+Riboflavin 10mg+Pyridoxine HCl 1.5mg tablets 17.07.15 56 Sodium Chloride 15%w/v+Glycerin 15%w/v enema 17.07.15 Clobetasol Propionate Eq. to Clobetasol BP 0.05%w/w+Salicylic Acid IP 6%w/w+Gentamycin Sulphate eq. to 57 17.07.15 Gentamycin BP 1%w/w+Methyl Paraceb Sodium IP 0.15%w/w+Propyl Paraben Sodium IP 15%w/w cream PolymoxinB Sulpahte BP 5000IU+Neomycin Sulphate BP 3400LU+Zinc Bacitracin BP 400 LU in an ointment base, 58 17.07.15 ointment Bifidobacterium bifidum 480.0 million cfu+Bifidobacterium longum 480.0 million cfu+Lactobacillus sporogene 100.0 59 million cfu+Lactobacillus rhamnosus 480.0 million dfu+Saccharomycesboulardii 275.0 million cfu+Fructo oligo 17.07.15 saccharide 100mg capsules Pyridoxine Hydrochloride IP 0.75mg+Nicotinamide IP 15mg+Cyancobalamin IP 2.50mcg+Lysine Hydrochloride USP 60 250mg+Zinc Gluconate USP eq.
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