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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 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Acid IP 0.5mg capsules 6 Thiamine Mononitrate IP 5mg+Pyridoxine HCl IP 3mg+Cyanocobalamin IP 5mcg tablets 17.07.15 (NOC Withdrawn) 7 Ciprofloxacin 500mg+Tinidazole 600mg tablets 16.07.15 8 Cabonyl Iron 50mg+Folic Acid IP 0.5mg+Zinc Sulphate Monohydrate IP 61.8mg eq.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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