
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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