Notice regarding Evaluation of FDC by DTAB Sub-Committee which were ealier Considered as irrational in the assessment report of the Prof.Kokate Committee

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 thereofS. 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) 2S. 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) 3Signature of the Authorized representative: ____________________________________________ Name: ___________________________________________________________________________ Designation: ______________________________________________________________________ Date: _______________________________ Place: _______________________________ For Office Use: Identification No. 4List 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 IPFDC 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 IPFDC 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 tablets Cetirizine DHCl BP+ Phenylephrine HCl BP+ Paracetamol Uncoated 2994 5mg+5mg+500mg IP Tablets 2698 cetirizine dihydrochloride + phenylephrine+ paracetamol 5 mg+ 10 mg+ 325 mg tablets Cetirizine Dihydrochloride IP+ Phenylephirine HCl IP+ 3425 2mg+5mg+125mg Syrup Paracetamol IP cetirizine dihydrochloride+ paracetamol+ phenylephrine 2781 5 mg+ 500 mg+ 10 mg uncoated tablet hydrochloride Uncoated 3149 Cetirizine HCl IP+ Paracetamol IP+ Phenylephrine HCl IP 5mg+325mg+5mg Tablets Cetirizine HCl IP+ Paracetamol IP+ Uncoated 3051 5mg+325mg+5mg Phenylephrine HCL IP Tablets Cetirizine HCL IP+ Phenylephirine HCl IP+ Paracetamol 222 5mg+5mg+500mg Tablets IP 3097 Cetirizine HCl IP+ Phenylephirine HCl IP+ Paracetamol IP 2.5mg+1.25mg+125mg Oral Liquid 2.5mg+2.5mg/5mg+125m 2930 Cetirizine HCl ip+ Phenylephrine HCl IP+ Paracetamol IP Suspension g/250mg 3303 Cetirizine HCl IP+ Phenylephrine HCl IP+ Paracetamol IP 2mg+2.5mg+125mg Oral Liquid Uncoated 3442 Cetirizine HCl IP+ Phenylephrine HCl IP+ Paracetamol IP 2.5mg+5mg+325mg Tablets Film Coated 3043 Cetirizine HCL IP+ Phenylphrine HCl IP 5mg+10mg Tablets Cetirizine HCl IP+ 2544 Paracetamol IP+ 1.0mg+125mg+2.5mg Oral drops Phenylephrine HCl IP Cetirizine HCl IP+ Uncoated 2962 Paracetamol IP+ 5mg+325mg+5mg Tablets Phenylephrine HCl IPFDC Identification Name of the FDC Strength Dosage Form No. 2541 Cetirizine HCl IP+Phenylephirine HCl IP+Paracetamol IP 5mg+5mg+325mg Tablets Cetirizine HCl+ 3213 2.5mg+2.5mg+125mg Suspension Phenylephrine HCL+ Paracetamol Cetirizine HCl+ Uncoated 2985 5mg+5mg+500mg Phenylephrine HCl+ Paracetamoml IP Tablets cetirizine hydrochloride + phenylephrine HCL+ 2861 5 mg+ 5 mg+ 500 mg uncoated tablet paracetamol Cetrizine Dihydrochloride+ 277 2.5mg+2.5mg+125mg Liquid Phenylpherine HCl+ Paracetamol 3340 Cetrizine HCl IP+ Phenylephirine HCl IP+ Paracetamol IP 2mg+2.5mg+125mg Liquid Oral 2824 cetirizine HCL+ phenylephrine hydrochloride 10 mg+ 10 mg tablets Cetirizine HCl+ 2807 10mg+10mg Tablets Phenylephrine HCl Cetirizine HCL+ 2842 5mg+20mg Tablet Phenylephrine HCL Cetirizine HCl+ 3260 2.5mg+2.5mg Oral liquid Phenylephrine HCl Cetirizine HCl+ 3191 5mg+20mg Tablets Phenylephrine HCL SR Cetrizine HCL+ 3.25mg+1.25mg+15mg+5 2715 Syrup Terbutaline sulphate+ Ambroxol HCL+Guaiphenesin 0mg Cetyl Myristoleate+ Glucosamine Sulpahte Potassium+ 102.5mg+500mg+ 5747 Tablets Metyl Solfonyl methane 200mg Cetyl Myristoleate+Glucosamine Sulphate 102.5mg eq. to 20.5mg Film Coated 319 Potassium+Methyl Sulfonyl Methane +500mg+200mg Tablets 1% w/w + 1.6%w/w + 4120 Chlorphenesin IP'85+Zinc Oxide IP+Starch IP Powders 11% w/w chlorpheniramine maleate + naphazoline HCL+ 0.10%w/v+0.05% w/v+ 2398 phenyl epherine HCL+ camphor+ menthol+ benalkonium 0.12%w/v+0.01% w/v + eye drops chloride solution 0.005%w/v 1.25%w/v + 0.01%w/v + Chlorpheniramine Maleate IP+ Naphazoline HCL IP+ Zinc 0.56%w/v + 0.012%w/v + 2458 Sulphate IP+ Sodium Chloride IP+ Eye Drops 0.05%w/v + 0.25%w/v + Hydroxyl Propyl Methyl Cellulose IP+Chlorbutol IP 0.5%w/v Chlorpheniramine Maleate IP+Naphazoline HCL USP+ 0.01%w/v + 0.1%w/v + 2473 Hydroxylpropylmethylcellulose IP+Benzalkonium Chloride Eye Drops 0.2%w/v + 0.02%v/v IP Chlorpheniramine maleate IP+Sodium Chloride IP+ 0.03%w/v+0.05%w/v+ Boric Acid IP+ 2365 1.25%w/v+0.01%w/v+ Eye Drops Tetrahydrozoline HCl+ 0.02%w/v Benzalkonium ChlorideFDC Identification Name of the FDC Strength Dosage Form No. Chlorpheniramine Maleate+P.G Sulphonate+ Ammonium 10mg+30mg+60mg+ 2884 Chloride+ Syrup 47mg+0.3mg Sodium Citrate+Menthol Chlorpheniramine maleate+Phenylephrine 0.2%w/v+0.12%w/v+ 2385 Eye Drops HCl+antipyrine+Chlorobutol 0.1%w/v+0.5%w/v 4.80%w/v+9.0%v/v+ 3773 Chlorxylenol+Terpinol+Alcohol Absolute (Denatured) Gel 13.1%v/v Clindamycin Phosphate USP+Zinc Acetate+ 1% w/w + 1% w/w + 3578 Cream Methylparaben IP+ Propylparaben 0.2% w/w + 0.05% w/w 2329 clomifene + ubidecarenone 25 mg+ 50 mg tablets Film Coated 2301 Clomifene Citrate IP+ Ubidecarenone BP 25mg/50mg+50mg Tablets 2318 Clomifene Citrate IP+ Ubidecarenone BP 25mg+30mg Oral Tablet 2326 Clomifene Citrate IP+ Ubidecarenone BP 50mg+50mg Tablets 2295 Clomifene Citrate IP+Ubidecarenone BP 25mg+50mg Tablets 2298 clomifene citrate+ ubidecarenone 100 mg+ 100 mg tablets 2325 Clomifrene Citrate+ Ubidecarrnone 50mg+50mg Tablets Clomiphene Citrate IP+ Film Coated 2319 50mg+600mg N-Acetylcysteine USP Tablets cyproheptadine HCL+ thiamine HCL+ Riboflavine + 2mg+1mg+ 1mg+ 4882 syrup pyridoxine HCL+ Niacinamide 0.5 mg+ 10 mg Cyproheptadine Hydrochloride IP+Tricholine Citrate 2mg+250mg+1.25mg+ 2156 +Thiamine Hydrochloride IP+ Oral Liquid 1.25mg+0.5mg Riboflavine IP+Pyridoxine Hydrochloride IP Dextromethorphan Hydrobromide IP+ Chlorpheniramine 10mg+4mg+240mg+ 2623 Maleate IP+ Ammonium Chloride IP+ Sodium Citrate Syrup 240mg+1.25mg IP+Menthol IP Diacerin IP+Glucosamine Sulphate Potassium Chloride 50mg+750mg+250mg+ 14 USP+ MSM (Methylsulfonylmethane) USP+Cetyl Tablets 175mg Myristoleate (20%) Diclofenac Sodium IP+ 643 Paracetamol IP+ 25mg+75mg+1%v/v Injection Benzyl Alcohol IP 67 Paracetamol+Diclofenac Sodium+Benzyl Alcohol 75mg+25mg+1%w/v Injection Diclofenac Sodium IP+ Small Volume 680 Paracetamol IP+ 25mg+75mg+1%v/v Parenterals Benzyl ALCOHOL IP (Ampoules) Diclofenac Sodium IP-37.5 mg + Thiocolchicoside IP-2 6252 37.5mg+2mg Injection mg+ (as preservative) Benzyl Alcohol IP- 4% v/v- Dicyclomine Hydrochloride IP+Chlordiazepoxide 10mg+5mg+2.5mg+ Hard Gelatin 2268 IP+Clidinium Bromide USP+Rabeprazole Sodium IP (ER) 10mg retard capsules Diethyl Carbamazine Citrate IP+ Chlorphenitamine 4355 50mg+1mg Syrup Maleate IP Diethyl Carbamazine Citrate IP+Chlorpheniramine Uncoated 1381 250mg+4mg Maleate IP Tablets Diethyl carbamazine citrate IP+Chlorpheniramine Maleate 3413 0.12gms+3.0mg oral IPFDC Identification Name of the FDC Strength Dosage Form No. Diethyl Carbamazine Citrate IP+Chlorpheniramine 3421 100mg+2.5mg Syrup Maleate IP Diethyl Carbamazine Citrate IP+Chlorpheniramine 3429 150mg+5mg Tablet Maleate IP 2817 diethyl carbamazine citrate+ chlorpheniramine maleate 100 mg+ 2mg uncoated tablet Diethyl carbamzine citrate IP+ 4272 100mg+200mg Tablets Chlorpheniramine maleate IP Di-ethylcarbamazine Citrate IP+ Chlorpheniramine 3417 120mg+3mg Syrup Maleate IP Diethylcarbamazine Citrate IP+Chlorpheniramine Maleate Film Coated 1557 250mg+4mg IP Tablets Diethylcarbamazine Citrate IP+Chlorpheniramine Maleate Film Coated 1558 100mg+2mg IP Tablets Diethylcarbamazine Citrate+Chlorpheniramine Maleate 3461 50mg+1.25mg Tablets USP Diethylcarbamazine Citrate+Chlorpheniramine Maleate 3462 0.25g+5mg Tablets USP Film Coated 1507 Diethylcarbamazine Citrate IP+Levocetirizine HCl IP 150mg+2.5mg tablets Diethylcarbamazine+ 150mg/300mg+ Film Coated 2790 Levocetirizine 2.5mg/5mg Tablets 1502 Divalproex Sodium+Levetiracitam 200mg+500mg Suspension 150mg/300mg+ Film Coated 1485 Divalproex Sodium + Levetiracetam 250mg/500mg Tablets Film Coated 1487 Divalproex Sodium + Oxcarbazepine IP 250mg+150mg Tablets Film Coated Doxycycline HCl IP+ Ornidazole IP+ Bromelain + 100mg+500mg+80mg+ Tablets +Hard 5514 Lactobacillus Rhamnosus GR-1+ Lactobacillus Reuteri 500 million CFU + Gelatin RC-14 500 million CFU Capsules Doxycycline HCl IP+Betacyclodextrin Film Coated 302 100mg+50mg+15mg USP+Serratiopeptidase IP Tablets Each 10 ml contains: 6227 Aminophylline IP-100mg+ Ammonium chloride IP-100 100mg+100mg+50mg oral mg+ Sodium citrate IP-50 mg-liquid Ergotamine tartrate+Caffeine+ 1mg+100mg+250mg+ 498 Tablets Paracetamol+ Prochlorperazine maleate 2.50mg Erythromycin Stearate IP eq. to Erythromycin+Lactic Acid Uncoated 1092 500mg+60 Million spores Bacillus IH Tablets 400mg+500mg/325mg+1 Film Coated 97 Etodolac IP+Paracetamol IP+ Serratiopeptidase IP 5mg TAblets Film Coated 312 Etodolac IP+Paracetamol IP+Serratiopeptidase IP 400mg+500mg+15mg Tablets Etofylline BP+Theophylline anhydrous eq. to Theophylline Uncoated 3156 231mg+69mg+75mg IP hydrate+ Ambroxol HCl IP Tablets Etofylline BP+Theophylline anhydrous eq. to Theophylline Uncoated 2844 231mg+69mg+10mg IP hydrate+ Montelukast IP Tablets Soft gelatin 4382 Evening Primerose Oil Bp+ Cod liver Oil BP 500mg+300mg CapsulesFDC Identification Name of the FDC Strength Dosage Form No. Flavoxate HCL BP+ 2282 200mg+200mg Tablets Ofloxacin IP Flavoxate HCl BP+ Film Coated 902 200mg+200mg Ofloxacin IP Tablets Flavoxate HCl BP+ Uncoated 935 200+200mg Ofloxacin IP Tablets Flavoxate HCl BP+ Film Coated 948 200mg+200mg Ofloxacin IP Tablets Flavoxate HCL BP+ 2287 200mg+200mg Tablets Ofloxacin IP Flavoxate HCl+ 2285 200mg+200mg Tablets Ofloxacin 847 Flavoxate HCL+Ofloxacin 200mg+200mg Tablet Film Coated 1086 Flavoxate Hydrochloride BP+Ofloxacin IP 200mg+200mg Tablets Film coated 254 Flupirtine maleate+ Thiocolchicoside 100/100mg+4/8mg Tablet Uncoated Flupirtine Maleate+ 297 400mg+325mg Tablets Paracetamol IP bilayered Fungal Diastase (1:800) IP+Papain IP+Nux Vomica 5mg+0.25mg+ 5974 Tincture IP+Cardamom Tincture BP+Casein 0.00125ml+0.0075ml+ Oral Liquid Hydrolysed+Alcohol IP 22.5mg+5%v/v Fungal Diastase (1:800) IP+Papain IP+Nux Vomica 50mg+2.5mg+0.0125ml+ 5975 Tincture IP+Cardamom Tincture BP+Casein 0.075ml+225mg+ Oral Liquid Hydrolysed+Alcohol IP) 5%v/v Gamma Benzene Hexachloride IP-1.0 g + Benzocaine IP- 6236 1 g +3 g+100mL Liquid topical 3.0 g +Oil base to 100 ml-Liquid (external preparation) Gamma Benzene Hexachloride IP-1.0 g + Benzocaine IP- 6262 1 g +3 g+100mL 3.0 g +Oil base to 100 ml-Liquid (external preparation) Soft Gelatin 5404 Gamma Linolenic Acid + Methylcobalamin JP 120mg+500mcg Capsules 4724 Ginkgo biloba + methylcobalamin 40 mg+ 750 mcg capsule Ginkgo Biloba Extract USP+ Alpha Liopioc Acid IP+ 60mg+100mg+0.75mg+1. Hard Geletin 5526 Methylcobalamin JP+ Pyridoxine HCl IP 5mg Capsules Ginseng Extract+ Hard gelatin 5694 50mg+ 60 mg Dried Extract Of Ginkgo Biloba capsules 10 % w/w + 1 % w/w + glucosamine hydrochloride + diacerein + menthol + 3716 5 % w/w + 1 % w/w + oinment camphor+ capsaicin powder 0.05% w/w Glucosamine sulphate(added as glucosamine sulphate Film Coated 4219 sodium chloride)+Chondroitin Sulphate (added as 500mg+400mg Tablets chondroitin sulphate sodium) Glucosamine sulfate potassium chloride USP-410 mg 6316 410mg+100mg Chondroitin Sulphate-100 mg Glucosamine sulfate potassium chloride+ MSM+ sodium borate+copper sulphate pentahydrate+ manganese 750mg+200mg+0.5mg+0. 5326 Tablet sulphate+ 5mg+3mg+200IU vitamin D3FDC Identification Name of the FDC Strength Dosage Form No. Glucosamine Sulfate Sodium Chloride USP+ Manganese (as Manganese Sulphate BP)+ Boron (as Sodium Borate 750mcg+3mg+0.5mg+ Film Coated 6082 BP)+ Zinc (as Zinc Sulfate Monohydrate USP)+ Copper 3mg+0.5mg Tablets (as Coppre Sulphate BP) Glucosamine Sulpahte+Chondroitin Sulphate+ Methyl 750mg+100mg+250mg+2 Sulfonyl Methane+Vitamin D3+ Vitamin E+ Vitamin C+ 00IU+12.5mg+30mg+ 4863 Selenium+ Elemental Zinc+ Elemental Manganese+ Tablets 70mcg+4mg+3mg+ Elemental Chromium+ Elemental Copper+ Elemental 50mcg+0.5mg+0.5mg Boron glucosamine sulphate + methyl sufonyl methane + manganese sulphate + 500 mg+ 200 mg+ 4884 tablets Vit E acetate+ 10 mg+ 16 mg+ 200mg calcium Carbonate Glucosamine Sulphate IP+ Vitamin E Acetate BP+ 500mg+8mg+50mg+ Film Coated 5431 Calcium Pantothenate IP+ Vitamin D3 IP 400 IU Tablets Glucosamine Sulphate Potassium Chloride IP+625mg of Film Coated 5674 Calcium Carbonate from an organic source (oyester shell) 750mg+250mg+125 IU tablets eq. to elemental Calcium+Vitamin D3 IP Glucosamine Sulphate Potassium Chloride USP+ Cetyl 500mg+102.5mg+ 5885 Tablets Myristoleate 20% + Methylsulfonylmethane USP 200mg Glucosamine Sulphate Potassium Chloride USP+ Methyl 750mg+250mg+250mg+2 4803 Sulphonyl methane USP+ Calcium carbonate IP+ Vitamin Tablets 5mg+4.5mg+20mg E IP+ Manganese Glucosamine sulphate potassium chloride+ Calcium Carbonate IP+ 750mg+250mg+200mg+1 Film Coated 5425 Methyl Sulphonyl Methane+ 25 IU Tablets Vitamin D3 IP Glucosamine Sulphate Potassium+Methyl Sulphate Sodium+Sulphonyl Methane+ Chondroitin Sulphate 750mg+200mg+200mg+2 4861 Sodium+ Calcium Carbonate+ Vitamin D3+Sodium 00mg+200mg+150mcg+0 Tablets Borate+ Cupric Oxide+ Colloidal Silicon Dioxide+ .7mg+2mg+2.5mg Manganese Chloride Heparin Sodium IP+ 3985 Benzyl Nicotinate+ 50 IU+2mg+1.97mg Ointment Sorbic Acid IP Hydroquinone USP+Octyl Methoxycinnamate+ 2.0% w/w + 5.0% w/w + 4362 Cream Oxybenzone USP 30.% w/w 2%w/v + 1%w/v + Ketoconazole IP+Zinc Pyrithione+D-Panthenol IP+Tea 3879 0.25%w/v + 0.5%w/v + Lotion Tree Oil BP+Aloes IP 5%w/v 2%w/w+10%w/w+ 5584 Ketoconazole+Aloe Vera+ Vitamin A Acetate Drops 0.05%w/w 3886 Ketoconazole+Aloes+ZPTO 2% + 10% + 1% Solution Ketoconazole+Shale Oil sulfonate (Icthyol Pale)+D- 2.00% w/v + 0.2% w/v + 4452 Shampoo Panthenol BP+Aloevera 1.0% w/v Ketorolac tromethamine+ chlorpheniramine maleate+ 0.5%w/v+0.02%w/v+ 2410 Phenylephrine HCL+ Opthalmic Drop 0.12%w/v+0.25%w/v Hydroxy propylmethyl cellulose Ophthalmic 2349 Ketoroloc Tromethamine IP+ Fluorometholone USP 0.4% w/v + 0.1% w/v Solution 3906 Kojic Acid + Arbutin+ Octinoxate + Vitamin E +Mulberry 2%+1.5%+7.5%+1% Cream Paracetamol IP+ Phenylephirine HCl IP+ Levocetirizine Uncoated 3100 325mg+2.5mg+2.5mg HCl IP tabletFDC Identification Name of the FDC Strength Dosage Form No. Levocetirizine HCl IP+ Phenylephrine HCl IP+ Uncoated 3134 5mg+5mg+325mg Paracetamol IP Tablets Levocetirizine Dihydrchloride+ 2629 5mg+10mg+500mg Tablets Phenylephrine HCl IP+ Paracetamol IP 2585 Levocetirizine HCL+ Phenylephrine HCL 2.5 mg + 10 mg Tablets 2887 Levocetirizine HCl+ Phenylephrine HCl 5mg+30mg SR tablets Levocetirizine+ 2886 2.5mg+10mg Syrup Phenylephrine HCl Film Coated 3091 Levocetrizine DiHCl+ Phenylephrine HCl 5mg+20mg Tablets Uncoated bi 2742 Levocetrizine HCL+ Phenylephrine HCL 5mg+20mg layer Tablet Levocetirizine Hydrchloride IP+Phenylephrine Uncoated 3505 5mg+30mg Hydrchloride IP(In sustained release form) bilayered tablet Levocetirizine Hydrochloride IP+ Phenylephrine Uncoated 3525 2.5mg+10mg Hydrochloride IP Tablets 3235 Levocetirizine Dihydrochloride IP+ Phenylephirine HCl IP 5mg+10mg Tablets Film Coated 3464 Levocetirizine IP+Diethyl Carbamazine Citrate 2.5mg+150mg Tablets Film Coated 3469 Levocetirizine IP+Diethyl Carbamazine Citrate 5mg+300mg Tablets Levocetirizine dihydrochloride IP+Diethylcarbamazine Film Coated 3526 2.5mg+150mg Citrate IP Tablets Film Coated 3164 Levocetirizine HCl IP+ Ambroxol HCl IP+ Paracetamol IP 5mg+60mg+325mg tablets Levocetirizine HCl+ Phenylephrine HCl+ 5mg/2.5mg+10mg/10mg+ 2885 Tablets Ambroxol HCl 60mg/60mg Levocetirizine HCl+ Phenylephrine HCl+ Film Coated 3074 5mg+5mg+50mg Ambroxol HCl Tablets Levocetirizine Hcl+ Uncoated 2609 Ambroxol HCl+ 5mg+60mg+2.5mg tablets Phenylephrine HCl 1mg+ .02 mg+ 70 mg+ 10 3685 lornoxicam + capsaicin 95% powder + menthol+ camphor liniment mg 0.125% w/w + 0.125% Lornoxicam+Thicolchicoside IP+Oleum Lini+Menthol 3587 w/w + 3% w/w + 5% w/w Gel IP+Methylsalicylate IP + 10% w/w 283 Meclizine HCl+ Paracetamol+Caffeine 25mg+500mg+50mg Tablets Mefenamic Acid+ 484 50mg+150mg+2%w/v Liquid Injection Paracetamol+Benzyl Alcohol Menthol IP+Aloe Vera Gel+Insert Solvent & Propellant 19% w/w + 01.00% w/w + Topical Pain 4067 Deodorised LPG q.s. to (Butane, Isobutane, Propane) 100% Releief Spray Menthol+Lignocaine HCl+Aloe Vera gel+ clotrimazole+ 1%w/w+0.5%w/w+0.5%w 4039 Topical Gel Diphenhydramine HCl /w+1.0%w/w+2%w/wFDC Identification Name of the FDC Strength Dosage Form No. 250 mg/500mg+ 70 metadoxine + silymarin+ L- ornithineL-asartate + mg/140 mg+ 75 mg/ 150 film coated 4979 folic acid+ pyridoxine HCL mg+ 1 mg/2 mg+ tablet 3 mg/6 mg 250mg/500mg+ Metadoxine+Silymarin (70%)+L-Ornithine L- 70mg/140mg+ 4742 Tablets Aspartate+Folic Acid IP+Pyridoxine HCl 75mg/150mg+1mg/2mg +3mg/6mg Metadoxine+Silymarin (70%)+L-Ornithine L-Aspartaten+ 250mg+70mg+75mg+ Film Coated 4697 Pyridoxine HCl + Folic Acid IP 3mg+1mg Tablets Metadoxine+Silymarin (70%)+L-Ornithine L-Aspartaten+ 500mg+140mg+150mg+3 Soft Gelatin 4685 Pyridoxine HCl +Folic Acid Ip mg+1.5mg Capsules Metadoxine+Silymarine+L-ornithine L-Aspartate+ 500mg+140mg+50mg+ 5193 Tablets Pyridoxine HCl IP+Folic Acid IP 3mg+1.5mg Methocarbamol USP+Diclofenac Sodium IP+ Benzyl 4461 Alcohol IP (As Preservative) 300mg+50mg Injection Miconazole nitrate IP- 2.00% w/w + Gentamicin Sulphate 2.00% w/w+0.2% w/w+ 6224 IP eq. to Gentamicin-0.2% w/w+ Fluocinolone Acetonide Cream 0.01% w/w+2.50% w/w IP-0.01% w/w+ Zinc Sulphate IP-2.50% w/w Miconazole USP+ 4158 2.0% w/v + 2.0% w/v lotion Tinidazole USP 2.0%/5.0%w/v+1.5%1/1.0 Topical 3709 Minoxidil + Aminexil + Absolute Alcohol 5%w/v+63%v/v / 40%v/v Solution 2.0% w/v + 1.50% w/v + Topical 4369 Minoxidil IP+ Aminexil+ Alcohol 63% v/v Solution 2.0%w/v/5%/4% + Minoxidil IP+Aminexil+Alcohol 95% v/v eq to absolute Topical 3949 1.5%w/v/1.5%.1.5% + Alcohol Solution 63%v/v/40%/40% Minoxidil IP+Aminexil+Alcohol 95%v/v eqvt. To absolute 5%w/v + 1.5%w/v + 4259 Topical alcohol 40%v/v Minoxidil+Azelaic Acid+ Topical 3916 10%w/v+5%w/v+3%v/v saw palmetto Solution Minoxidil IP+Azelaic Acid + 3.0%w/v + 1.5%w/v + Topical 3933 saw palmetto 1.5%w/v Solution Topical 3862 Minoxidil+Aminexil 5.0%w/v + 1.5%w/v Solution 0.1%w/v + 0.2%w/v + Naphazoline HCl BP+Hydroxyl Propyl Methyl Cellulose 3.0%w/v + 0.05%w/v + 1788 IP+Boric Acid IP+Borax BP+Menthol IP+Camphor IP 66+ Ear Drops 0.0025%w/v + BKC IP 0.0025%w/v + 0.02%w/v naphazoline HCL IP+Chlorpheniramine Maleate IP+Zinc 0.56mg+0.10mg+ Sulphate IP+ 1776 1.20mg+2.00mg+ Ear Drops Hydroxypropylmethycellulose IP+Benzalkonium Chloride 0.0001 per ml IP 0.056% w/v+ 0.12 % w/v naphazoline HCL + zinc sulphate + boric acid+ opthalemic 2421 + 1.25 % w/v+ 0.05 % w/v sodium chloride + chlorpheniramine maleate drops + 0.01 % w/vFDC Identification Name of the FDC Strength Dosage Form No. Naphazoline HCl USP+ Chlorpheniramine Maleate IP+ 0.56mg+0.1mg+1.2mg+2 Ophthalmic 2462 Zinc Sulphate IP+ mg+0.0001ml Solution Hydroxyl Methylcellulose IP+ Benzalkonium Chloride IP Naphazoline HCl USP+ Chlorpheniramine Maleate IP+ 0.056%w/v + 0.01%w/v + Zinc Sulphate IP+ Ophthalmic 2465 0.12%w/v + 0.2%w/v + Hydroxyl Methylcellulose IP+ Solution 0.0001ml Benzalkonium Chloride IP Naphazoline HCl USP+ Hydroxy Propyl Methyl Cellulose IP+ 0.056% w/v + 0.25% w/v Chlorpheniramine Maleate IP+ Zinc Sulphate IP+ + 0.01%w/v + 1.25% w/v Ophthalmic 2381 Boric Acid IP+ +0.05% w/v +0.05% w/v Solution Sodium Choride IP+ +0.35% w/v Chlobutol IP Naphazoline Hcl USP+ Hydroxypropylmethycellulose+ 0.1% w/v + 0.1% w/v + 2394 Eye Drops Chlorpheniramine maleate + Boric Acid 0.01% w/v + 1.25%w/v Naphazoline HCl USP+ Hydroxypropylmethylcellulose IP+ 0.56% w/v + 0.2% w/v + Chlorpheniramine Maleate IP+ Boric Acid IP+Sodium 2362 0.01% w/v + 1.25% w/v + Eye Drops Chloride IP+ 0.05% w/v +0.12% w/v Zinc Sulphate IP Naphazoline HCl USP+Chlorpheniramine Maleate 0.1% w/v + 0.01% w/v + 2360 Eye Drops IP+Methylcellulose IP 0.2% w/v 0.1%w/v + 0.2%w/v + Naphazoline HCl USP+Hydroxyl Methylcellulose IP+ Boric 3.0%w/v + 0.05%w/v + 2478 Eye Drops Acid IP+Menthol IP+ Camphor IP '96' 0.0025%w/v + 0.0025%w/v Naphazoline HCl USP+Hydroxypropylmethylcellulose 0.056% w/v + 0.2% w/v + 2347 IP+Chlorpheniramine Maleate IP+Zinc Sulphate IP+ 0.12% w/v + 0.1% w/v + Eye drops Benzalkonium Chloride Solution IP (As Preservative) 0.12% w/v +0.01% w/v 0.1% w/v + 0.1% w/v + Naphazoline HCl USP+Methylcellulose IP+ 0.01% w/v + 1.25% w/v + Chlorpheniramine Maleate IP+ Boric Acid IP+ 2357 0.05% w/v + 0.012% w/v Eye Drops Sodium Chloride IP+Zinc Sulphate IP+ Menthol IP+ + 0.0025% w/v + Camphor IP '66' 0.0025% w/v 0.05% w/v + 0.12% W/v + Naphazoline HCl USP+Phenylepherine HCl IP+HPMC 2363 0.20% w/v +0.01% w/v Eye Drops IP+Chlorpheniramine Maleate IP+Menthol IP+Camphor IP +0.01% w/v+0.01% w/v 0.1 w/v +0.1 % w/v + 0.01 naphazoline hydrochloride+ hydroxypropylmethylcellulose % w/v + 1.25 w/v + 0.05 2411 + chlorpheniramine maleate + boric acid + sodium % w/v + 0.12 % w/v eye drops chloride + zinc sulphate + menthol + camphor +0.0025% w/v + 0.0025 % w/v Naphazoline Hcl+ 0.056%w/v+0.1%w/v+ Hydroxypropylmethycellulose+Chlorpheniramine 0.01%w/v+0.25%w/v+ 2384 maleate+ 0.5%w/v+0.12%w/v+ ophthalmic Boric Acid+Sodium Chloride+ 0.0025%w/v+ Zinc sulphate+ Menthol+ Camphor 0.0025%w/v Naphazoline HCl+Azelastine HCl+Sodium Carboxy Methyl 0.1%w/v+0.05%w/v+0.5% 1774 Cellulose+Menthol+Camphor+Stabilized oxychloro w/v+0.005%w/v+0.01%w/ Drops complex v+0.005%w/v 0.1%w/v+0.5%w/v+0.005 Naphazoline HCl+Sodium Carboxymethylcellulose+ 1771 %w/v+0.01%w/v+0.005% Nasal Spray Menthol+Camphor+Stabilized Oxychlorocomplex w/vFDC Identification Name of the FDC Strength Dosage Form No. Naphazoline hydrochloride+ Hydroxypropylmethylcellulose 0.1% w/v + 0.1% w/v + 2412 + Chlorpheniramine maleate + Boric acid + Zinc sulphate 0.01% w/v + 1.25%w/v + Eye Drops + Benzalkonium Chloride 0.1% w/v + 0.02% v/v Naphazoline Nitrate IP+ Chlorpheniramine Maleate IP+ 0.05%w/v + 0.01%w/v + Phenylephrine HCl IP+ 0.12%w/v + 0.2%w/v + 2446 Hydroxyl Methyl Cellulose IP+ Eye Drops 1.25%w/v + 0.005%w/v + Boric Acid IP+Menthol IP+ Camphor IP+ 0.01%w/v + 0.02%v/v Benzalkonium Chloride IP 0.056% w/v + 0.01% w/v Naphazoline Nitreate IP+Chlorphiniramine Maleate 2358 + 0.012% w/v + Eye Drops IP+Zinc Sulphate IP+ Boric Acid IP+ Sodium Chloride IP 1.25% w/v + 0.05% w/v Hard Geletin 2030 Naproxen IP+ Esomeprazole Magnesium Trihydrate IP 375mg+20mg Capsules Hard Gelatin 2137 Naproxen IP+Pantoprazole IP 250mg/500mg+20mg Capsules Film Coated 1533 Nicergoline BP+Vinpocetine BP 5mg+5mg Tablets 1089 Norfloxacin IP+Tinidazole (With Betacyclodextrin) IP 1.0% w/w + 0.5% w/w Eye Ointment Ofloxacin IP+Beclomethasone Dipropionate 0.3%w/v + 0.025%w/v + 1781 Ear Drops IP+Lignocaine HCl IP 1%w/v / 2%w/v 2112 Omeprazole Magnesium+ Dicyclomine HCl 10mg+10mg Tablets Omeprazole Magnesium+ Enteric Coated 2217 10mg+10mg Dicyclomine HCl IP Tablets 2819 paracetamol + cetirizine HCL+ phenylephrine HCL 325 mg+ 5 mg+ 5 mg uncoated tablet paracetamol + cetirizine hydrochloride + 2858 325 mg+ 5 mg+ 5 mg tablet phenylephrine HCL paracetamol + cetirizine hydrochloride + phenylephrine 325 mg+ 5 mg+ 2534 tablet hydrochloride 5 mg/10 mg paracetamol + cetirizine hydrochloride + phenylephrine 2865 125 mg+ 2.5 mg+ 2.5 mg suspension hydrochloride Paracetamol IP 450mg+ Bromhexine HCl IP 8mg+ GuaiphenesinIP 50mg+ Chlorpheniramine Maleate IP 450mg+8mg+50mg+ 6284 Tablets 2mg+ 2mg+5mg Phenylephrine HCl IP 5mg tablets Paracetamol IP+ Chlorpheniramine Maleate IP+ Phenyl 3416 500mg+2mg+25mg Tablet Propanolamine HCL BP Film Coated 3113 Paracetamol IP+ Levocetirizine HCl IP+ Ambroxol HCl IP 325mg+5mg+60mg tablets 3240 Paracetamol IP+ Phenylephirine HCl IP+ Cetirizine HCl IP 325mg+5mg+5mg Tablets Paracetamol IP+ Phenylephrine HCl IP+ Cetirizine Uncoated 2633 325mg+10mg+5mg Dihydrochloride IP TabletsFDC Identification Name of the FDC Strength Dosage Form No. 3040 Paracetamol IP+ Phenylephrine HCl IP+ Cetirizine HCl IP 125mg+5mg+2.5mg Suspension Uncoated 3101 Paracetamol IP+ Phenylephrine HCl IP+ Cetirizine HCl IP 325mg+5mg+5mg tablet Uncoated 3180 Paracetamol IP+ Phenylephrine HCl IP+ Cetirizine HCl IP 325mg+5mg+5mg Tablets 3184 Paracetamol IP+ Phenylephrine HCl IP+ Cetirizine HCl IP 125mg+2.5mg+2.5mg Oral Liquid Uncoated 3231 Paracetamol IP+ Phenylephrine HCl IP+ Cetirizine HCl IP 325mg+5mg+5mg tablet 325mg/500mg/125mg+ Uncoated 3245 Paracetamol IP+ Phenylephrine HCl IP+ Cetirizine HCl IP 5mg/2.5mg+5mg/2.5mg tablet Uncoated 3503 Paracetamol IP+ Phenylephrine Hcl IP+ Cetrizine HCl IP 650mg+10mg+5mg Tablets Paracetamol IP+ 500mg/500mg+ 2559 Cetrizine HCl IP+ Tablets 5mg/5mg+10mg/5mg Phenylephrine HCl IP Paracetamol IP+ Diclofenac Sodium IP+ 500mg+50mg+100mg+ Uncoated 593 Magnesium Trisilicate IP+ 2mg Tablets Chlorpheniramine Maleate IP Paracetamol IP+ 3 150mg+100mg per ml Injection Nimesulide BP Paracetamol IP+ 376 500mg+15mg Tablets Pentazocin HCl IP Paracetamol IP+ Uncoated 3361 Phenylephrine Hydrochloride IP+ Cetirizine Hydrochloride 500mg+5mg+5mg Tablets IP Uncoated 3380 Paracetamol IP+Cetirizine HCl IP+Phenylephrine HCl IP 325mg+5mg+5mg Tablets Oral Liquid 3457 Paracetamol IP+Cetirizine HCl IP+Phenylephrine HCl IP 125mg+2.5mg+2.5mg Syrup Paracetamol IP+Diclofenac Potassium BP+ Uncoated 439 325mg+50mg+30mg Caffeine Anhydrous IP Tablets Ergotamine tartrate+Caffeine+ Paracetamol+ 1mg+100mg+250mg+ Uncoated 516 Prochlorperazine maleate 2.5mg tablet Paracetamol IP+Ergotamine tyartrate IP+Caffeine IP+ 250mg+1mg+100mg+ 262 Tablets Prochlorperazine Maleate IP 2.5mg 3599 Paracetamol IP+Phenylephrine HCl IP+Cetirizine HCl IP 125mg+2.5mg+2.5mg Topical Use 3069 Paracetamol+ Phenylephrine+ Cetirizine 325mg+5mg+5mg Tablets Paracetamol+ Uncoated 3206 Phenylephrine HCl+ 325mg+5mg+5mg tablet Cetirizine Di HClFDC Identification Name of the FDC Strength Dosage Form No. Paracetamol+ 3209 Phenylephrine HCl+ 325mg+5mg+5mg Tablets Cetirizine Di HCl Paracetamol+ 2840 Phenylephrine HCL+ 325mg+5mg+5mg Tablet Cetrizine HCL 2899 Paracetamol+Phenylephrine+Cetirizine Di Hydrochloride 125mg+5.0mg+2.0mg Liquid oral Phenylepherine HCL IP+Naphazoline HCl 0.12% w/v + 0.05% w/v + 2382 USP+Chlorpheniramine Maleate IP+Menthol IP+Camphor 0.1% w/v +0.005% w/v + Eye Drops IP+Benzalkonium Chloride Solution IP 0.01% w/v +0.01% w/v Phenylepherine HCl IP+Naphazoline HCl USP+Menthol IP+ 0.012% w/v + 0.05% w/v 2356 Camphor IP '66'+ +0.005% w/v + Eye Drops Hydroxypropylmethylcellulose IP 0.01% w/v + 0.25% w/v Phenylephirine HCL IP+ Naphazoline HCL IP+ 0.12%w/v + 0.05%w/v+ 2459 Menthol IP+ Camphor IP+ Hydroxyl Propyl Methyl 0.005%w/v + 0.01%w/v + Eye Drops Cellulose IP+ BKC IP 0.25%w/v + 0.01%v/v Phenylephirine HCl IP+ Naphazoline HCL USP+ Menthol 0.12%w/v + 0.05%w/v + Ophthalmic 2443 IP+Camphor IP+ Hydroxyl Propyl Methyl Cellulose IP+ 0.005%w/v + 0.01%w/v + Drops Benzalkonium Chloride IP 0.25%w/v + 0.01%v/v Phenylephrine HCL+ Naphazoline HCL+ 0.12%w/v+0.05%w/v+ 2408 Opthalmic Drop Menthol+camphor 0.005%w/v+0.01%w/v Phenylephirine HCl IP+naphazoline HCl USP+Menthol 0.12% w/v + 0.05% w/v 2361 IP+ +0.005% w/v+ Eye Drops Camphor IP '66' 0.01% W/v Phenylephrine HCl IP+ Ambroxol HCL IP+ Guaiphenesin Film Coated 2636 5mg+60mg+50mg IP Tablets Uncoated 3285 Phenylephrine HCl IP+ Cetirizine HCl IP+ Paracetamol IP 10mg+5mg+325mg Tablets Phenylephrine HCl+ Paracetamol+ Levocetirizine 5mg+250mg+0.8mg+ 3197 Syrup HCl+Menthol 1.25mg Phenylephrine HCl IP+ Paracetamol IP+ Levocetirizine 5mg+125mg+1.25mg+ 2915 HCl IP+ Oral Liquid 1mg Menthol IP Phenylephrine Hcl IP+ Naphazoline HCL USP+ 0.12%w/v + 0.05%w/v+ Menthol IP+ 2470 0.005%w/v + 0.01%w/v + Eye Drops Camphor IP '66 + 0.1%w/v + 0.01%w/v Hydroxyl propyl methyl cellulose IP+ Benzalkonium Chloride Solution IP Phenylephrine HCL+Naphazoline 0.12%w/v+0.05%w/v+ 2389 HCL+Menthol+Camphor+ 0.005%w/v+0.01%w/v+ Eye Drops Benzalkonium Chloride 0.01%w/vFDC Identification Name of the FDC Strength Dosage Form No. Phenylephrine HCl IP+Naphazoline HCL USP+Menthol 0.12%w/v + 0.05%w/v + IP+ 2433 0.005%w/v + 0.01%w/v + Eye Drops Camphor IP+ 0.02%w/v Benzalkonium Chloride IP Phenylephrine HCl+ 2876 5mg+60mg+50mg Tablets Ambroxol HCl+Guaiphenesin Phenylephrine HCl+ Hard gelatin 3287 10 mg +5 mg Cetirizine HCl (as pellets) capsules 2656 phenylephrine+ cetirizine+ paracetamol 5 mg+5 mg+ 500 mg uncoated tablet Pine Bark Extract+Kojic Acid+Sodium Ascorbyl 0.4% w/w + 2.0% w/w + 3655 Cream Phosphate 1.0%w/w film coated 1440 piracetam + Ginkgo biloba extracts 400 mg+ 60 mg tablet film coated 1441 piracetam + Ginkgo biloba extracts + vinpocetin 800 mg+ 60 mg+ 5 mg tablet 1503 Piracetam+Ginkgo Biloba+Vinpocetin 800mg+60mg+5mg Tablets Povidone Iodine IP 5%w/v+ Tinidazole IP 1%w/v+ 6291 5%w/v+1%w/v+1%w/v Solution Zinc Sulphate IP 1%w/v solution 5% w/w + 1% w/w + 1149 Povidone Iodine IP+Ornidazole IP+Dexpanthenol USP Ointment 5% w/w 5% w/w + 1% w/w + Topical 3617 Povidone Iodine IP+Ornidazole IP+Dexpanthenol USP 5% w/w Ointment 20mg/20 mg/40 mg+ 0.25 1182 propranolol hydrochloride + etizolam tablet mg/0.5 mg/ 0.5 mg Rabeprazole Sodium EC+Clindinium 10mg+2.5mg+10mg+ 1868 Capsules Bromide+Dicyclomine HCL+Chlordiazepoxide 5mg 50 mg+250 mg+ 50 mg+ S- adenocyl methionine+ metadoxine+ ursodeoxycholic 200 mcg+ 30 mg + enteric coated 1910 acid + chloine bi tratrtae+ silymarin+ 70 mg+ 75 mg+ 8 mg + tablet L-ornithine L- aspartate+ inositol+ taurine 50 mg Salbutamol Sulphate+ Bromhexine HCl+ 2 mg + 4 mg + 66 mg 3057 Syrup Guaifenesin IP+ Ammonium Chloride+ Menthol IP +100 mg + 1 mg 2%w/v + 5%w/v + 4033 Salicylic Acid IP+Aloe Vera+ Allantoin IP+ D-Panthenol IP Cream 0.1%w/v + 0.2%w/v 1%w/w + 15%w/w + 4003 Sildenafil Citrate IP+ Papaverine+ L-Arginine IP Cream 0.5%w/w 1%w/w+0.2%w/w+ Silver Sulphadiazine + Chlorhexidine Gluconate Solution 3771 0.1%w/w+15%w/w+ Cream + Allantoin + Aloe Vera Gel + Vitamin E Acetate 0.2%w/wFDC Identification Name of the FDC Strength Dosage Form No. silymarin+ Thiamine Mononitrate+ Riboflavin+ Pyridoxine 70 mg+ 5 mg+ 5 mg+ 1.5 4715 HCL+ Niacinamide + calcium pantothenate+ Vitamin mg+ 25 mg+ Capsules B12+ exipient 7.5 mg+ 5 mcg+q.s Silymarin+Pyridoxine HCl+Cyanocobalamin+ 70mg+1.5mg+1mcg+ 2150 Capsules Niacinamide IP+Folic Acid IP 25mg+0.3mg 35mg+1mg+2.5mcg+ Silymarin+Vitamin B6 IP+Vitamin B12 IP+Niacinamide 2149 22.5mg+750mcg+ Oral Liquid IP+Folic Acid IP+Tricholine Citrate 65% 500mg Sodium Citrate IP+Citric Acid Monohydrate IP Flavoured 2265 With Cardamom Oil, Caraway Oil , Cinnamon Oil, Clove 200mg+40mg+9.5% v/v Liquid Orals Oil, Ginger Oil+Acohol content 1.0%w/w+0.5%w/w+ Liquid in 3637 Sodium Salicylate+Zinc Gluconate+Pyridoxine HCl 0.5%w/w shampoo base Sucralfate USP+ Film Coated 286 500mg+100mg Aceclofenac IP Tablets Sucralfate USP+Domperidone Maleate IP eq. to Uncoated Ta 2166 Domperidone+ 500mg+10mg+25mg blets Dimethicone IP Sucralfate USP-1 g+ Domperidone BP-7.5 mg- 6235 1g+7.5mg suspension suspension Sucralfate+ 2052 500mg+5mg Suspension Domperidone Maleate 2040 Sucralfate+Domperidone + Simethicone 500mg+10mg+25mg Suspension Sucralfate+Pantoprazole Sodium+Zinc Gluconate+ 1000mg+20mg+10mg+ 2053 Powder Light Magnesium Carbonate 200mg Sulfaquinoxaline+ 37.4gm+6.6gm+ 3928 Powder Diaveridine HCl+ Vitamin K 2000mcg Sulphacetamide Sodium IP-15% w/v + Zinc Sulphate IP- 15%w/v+0.1%w/v+ 0.1% w/v + Chlorpheniramine Maleate IP-0.01% w/v + 6246 0.01%w/v+1.9%w/v+ Drops Boric acid IP-1.9% w/v + Sodium Chloride IP-0.1% w/v + 0.1%w/v+0.5%w/v Chlorbutol IP- 0.5 % w/v-Eye Drop Terbutaline Sulphate IP+ Bromhexine HCl IP+ 1.25mg/2.5mg+ Uncoated 3454 Chlorpheniramine Maleate IP 4mg/16mg+2mg/4mg Tablets 3900 Tetracycline HCl+Colistin Sulphate 14%w/w+1%w/w PowderFDC Identification Name of the FDC Strength Dosage Form No. 0.700 ml+0.600 ml+ Tincture Ipecacuanha IP66+Tincture Urgenia 1.300 ml+0.700 ml+ 2264 IP66+Camphorated Opium Tincture IP66+Aromatic Spirit Liquid Orals 0.020 ml+ Of Ammonia IP66+Chloroform IP+Alcohol Content 40 to 45% v/v Tramadol HCl BP+ Uncoated 541 Dicyclomine HCl IP+ 50mg+10mg+10mg Dispersible Domperidone BP tablets Tramadol HCl BP+ 37.5mg+325mg+30mg+2 Film Coated 536 Paracetamol IP+ 50mg Tablets Caffeine IP+Taurine USP 37.5 mg+ 325 mg+ 250 film coated 216 Tramadol HCL+ paracetamol+ taurine+ caffiene mg+ 30 mg tablet film coated 235 Tranexamic acid + mefenamic acid + vitamin K1 500 mg+ 325 mg+ 5 mg tablet Trithioparamethoxyphenyl Propene 12.5mg+ sugar coated 6288 12.5mg+3.0mg Chlorpheniramine Maleate IP 3.0mg sugar coated tablets tablets 1694 Ursodeoxycholic Acid+Metformin HCl SR 150mg+500mg Bilayered tablet Weak Ginge tincture BP+Aromatic Spirit Of Ammonia 0.625 ml+0.625 ml+ IP66+Peppermint Spirit BPC+Chloroform IP+Sodium 0.250 ml+0.019 ml+ 2262 Liquid Orals Bicarbonate IP+ Compound Cardamom Tr. IP66 + 0.275g+3.000 ml+ Alcohol content 20 to 26% v/v Weak Ginge tincture BP+Aromatic Spirit Of Ammonia 0.104 ml+0.104 ml+ IP66+Peppermint Spirit BPC+Chloroform IP+Sodium 0.041 ml+0.003 ml+ 2263 Liquid Orals Bicarbonate IP+Compound Cardamom Tr. IP66+Alcohol 0.046g+0.500 ml+ content 7.6% v/v Zinc Sulphate IP+ 0.1% w/v + 1.8% w/v + Boric Acid IP+ Naphazoline Hcl BP + Sodium Chloride 4490 0.2% w/v + 0.85% w/v + Eye Drops IP+ 0.5% w/v Phenyl ethyl alcohol USP