List of Drugs Registered in Accordance with the provisions of the Food and Drugs Act and Regulations Chapter 30:01
Year 2006 DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE 57210206 Extra Strength Rolaids Distributed by Pfizer Consumer Puerto Rico Freely Tablets - Fruit Healthcare USA (Product of Puerto Rico) 57220206 Children's Dimetapp DM Wyeth Consumer Healthcare USA Freely Cold & Cough Elixir-Red Grape (Alcohol-Free) 57230206T Survanta (beractant) Manufactured by Hospira, Inc. USA Third Schedule Intratracheal Suspension For Ross Products Division (To Abbott Laboratories USA Neonatologists, Paediatricians or Registrars in a Neonatal Unit ONLY) (FROM AGENT ONLY) 57240206T Momate Cream Glenmark Pharmaceuticals Ltd. India Third Schedule 57250206T Momate Ointment Glenmark Pharmaceuticals Ltd. India Third Schedule 57260206T Beclotis Inhaler BP 50mcg Jewim Pharmaceutical China Third Schedule per actuation (Shandong) Co., Ltd. 57270206T Salbutis Inhalation Aerosol Jewim Pharmaceutical China Third Schedule BP 100mcg per actuation (Shandong) Co., Ltd. 57280206 Fiberex Granules with Pure Made by Meyer Healthcare Pvt. India Freely Florida Orange Flavour Ltd. Exported by Meyer Organics Pvt. Ltd. India 57290206T Coversyl Tablets 8mg Les Laboratoires Servier France Third Schedule Industrie 57300206 Califig Syrup Merck Consumer Health England Freely 57310206T Glisulin 500 XR Extended Manufactured by Merck Santé Chile Third Schedule Release Tablets s.a.s. France Packaged by Merck S.A. 57320206 Aerius 0.5mg/ml Syrup Manufactured by Schering- Belgium Freely Plough Labo N.V. under authority of Schering-Plough Corporation USA 57330206 Fenistil Drops Novartis Consumer Health SA Switzerland Freely
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE 57340206T Bonviva Film-Coated F. Hoffmann-La Roche Ltd. Switzerland Third Schedule Tablets 150mg 57350206T Humalog Mix 25 100 Lilly France S.A. France Third Schedule IU/mL Suspension 57360206T Humalog U-100 Injection Eli Lilly & Company USA Third Schedule 100 units per mL 57370206T Partobulin SDF Solution for Baxter AG Austria Third Schedule Intramuscular Injection 1250 I.U. - Preloaded Syringe 57380206T Videx EC Delayed-Release Bristol-Myers Squibb USA Third Schedule Capsules 200mg Immunology A Bristol-Myers Squibb Company 57390206T Videx EC Delayed-Release Bristol-Myers Squibb USA Third Schedule Capsules 250mg Immunology A Bristol-Myers Squibb Company 57400206T Videx EC Delayed-Release Bristol-Myers Squibb USA Third Schedule Capsules 400mg Immunology A Bristol-Myers Squibb Company 57410206 H2K Iron Supplement + Manufactured by Atra India Freely Folic Acid Film-Coated Pharmaceuticals Ltd. For Health Tablets 2000 Inc. Canada 57420206 H2K Multivitamin Sugar- Manufactured by Atra India Freely Coated Tablets Pharmaceuticals Ltd. For Health 2000 Inc. Canada 57430206 H2K Vitamin B-Complex Manufactured by Atra India Freely Film-Coated Tablets Pharmaceuticals Ltd. For Health 2000 Inc. Canada 57440206T Pioglar Tablets 15mg Ranbaxy Laboratories Limited India Third Schedule 57450206T Pioglar Tablets 30mg Ranbaxy Laboratories Limited India Third Schedule 57460206T Simvor 80 Film-Coated Ranbaxy Laboratories Limited India Third Schedule Tablets 80mg 57470206T Vamlo Tablets 5mg Ranbaxy Laboratories Limited India Third Schedule 57480206T Vamlo Tablets 10mg Ranbaxy Laboratories Limited India Third Schedule 57490206T Corpril 2.5 Capsules 2.5mg Ranbaxy Laboratories Limited India Third Schedule 57500206T Corpril 5 Capsules 5mg Ranbaxy Laboratories Limited India Third Schedule 57510206T Coviro-E 30 Compliance Ranbaxy Laboratories Limited India Third Schedule Pack Tablets 57520206T Coviro-E 40 Compliance Ranbaxy Laboratories Limited India Third Schedule Pack Tablets 57530206T Virocomb-E Compliance Ranbaxy Laboratories Limited India Third Schedule Pack Tablets 57540206T Avostav Capsules 30mg Ranbaxy Laboratories Limited India Third Schedule 57550206T Avostav Capsules 40mg Ranbaxy Laboratories Limited India Third Schedule 57560206T Avolam Film-Coated Ranbaxy Laboratories Limited India Third Schedule Tablets 150mg 57570206T Aviro-Z Film-Coated Ranbaxy Laboratories Limited India Third Schedule
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE Tablets 300mg 57580206T Avocomb Film-Coated Ranbaxy Laboratories Limited India Third Schedule Tablets 57590206 QuikClot ACS Advanced Z-Medica Corporation USA Freely (For use Clotting Sponge by Emergency Medical Technicians ONLY) 57600206T Natrecor Lyophilized Made by Hospira Inc. For USA Third Schedule Powder for Reconstitution SCIOS Inc. USA (To Registered 1.5mg Cardiologist ONLY) (FROM AGENT ONLY) 57610206T Dibron Tablets Global Pharma Healthcare Pvt. India Third Schedule Ltd. 57620206 Transvasin Heat Rub Cream Distributed by Thornton & UK Freely (Change of Name of Ross Ltd. UK (Product of UK) Manufacturer)
57630206 Transvasin Heat Spray Distributed by Thornton & UK Freely (Change of Name of Ross Ltd. UK (Product of UK) Manufacturer) 57640206 Yeast Vite Tablets (Change Distributed by Thornton & UK Freely of Name of Manufacturer) Ross Ltd. UK (Product of UK) 57650206 Sominex Tablets (Change of Distributed by Thornton & UK Freely Name of Manufacturer) Ross Ltd. UK (Product of UK) 57660206 Mycota Cream (Change of Distributed by Thornton & UK Freely Name of Manufacturer) Ross Ltd. UK (Product of UK) 57670206 Mycota Spray (Change of Distributed by Thornton & UK Freely Name of Manufacturer) Ross Ltd. UK (Product of UK) 57680206 Mycota Powder (Change of Manufactured by Custom UK Freely Name of Manufacturer) Pharmaceuticals Ltd. For Thornton & Ross Ltd. UK 57690206T Cozaar Tablets 50mg Manufactured by MERCK Costa Rica Third Schedule (Change of Source) SHARP & DOHME DE MEXICO S.A. DE C.V. Mexico Packaged by MERCK SHARP & DOHME (I.A.) CORP. 57700206 Genprofen 200 Film-Coated Genethics Pharmaceuticals Ltd Trinidad & Freely Tablets 200mg (Change of Tobago Colour of Tablet Coating) 57710206T Gendazole Film-Coated Genethics Pharmaceuticals Ltd Trinidad & Third Schedule Tablets (Change of Size and Tobago Colour of Tablets) 57720206T Gendazole F Film-Coated Genethics Pharmaceuticals Ltd Trinidad & Third Schedule
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE Tablets (Change of Size and Tobago Colour of Tablets) 57730206T Gen-Amipril Tablets 5mg Genethics Pharmaceuticals Ltd Trinidad & Third Schedule (Change of Colour of Tobago Tablets) 57740206T Genfurosemide Tablets USP Genethics Pharmaceuticals Ltd Trinidad & Third Schedule (Change of Appearance of Tobago Tablets) 57750206T Genclamide Tablets BP 5mg Genethics Pharmaceuticals Ltd Trinidad & Third Schedule (Change of Name of Tobago Product) 57760206T Diaban Tablets 80mg Genethics Pharmaceuticals Ltd Trinidad & Third Schedule (Change of Shape and Tobago Appearance of Tablets) 57770206T Arimidex Tablets 1mg Manufactured by AstraZeneca USA Third Schedule (Removal of Claim: 'who are Pharmaceuticals LP For unable to take tamoxifen AstraZeneca UK Limited therapy') United Kingdom 57780206T Mycospor Onichoset Bayer, S.A. El Salvador Third Schedule Ointment 1% (Additional Source and Change of Artwork Design)
57790206T Baraclude Tablets 0.5mg Manufactured by Bristol-Myers USA Third Schedule (Additional Name of Squibb Company Subsidiary of Manufacturer) Bristol-Myers Squibb Company USA 57800206T Baraclude Tablets 1mg Manufactured by Bristol-Myers USA Third Schedule (Additional Name of Squibb Company Subsidiary of Manufacturer) Bristol-Myers Squibb Company USA 57810206T Baraclude Oral Solution Manufactured by Bristol-Myers USA Third Schedule 0.05mg/mL (Additional Squibb Company Subsidiary of Name of Manufacturer) Bristol-Myers Squibb Company USA 57820206T Paraplatin (carboplatin Bristol-Myers Squibb Oncology USA Third Schedule aqueous solution) Injection Bristol-Myers Squibb Company 50mg per vial (10mg/mL) (Additional Name of Manufacturer) 57830206T Paraplatin (carboplatin Bristol-Myers Squibb Oncology USA Third Schedule aqueous solution) Injection Bristol-Myers Squibb Company 150mg per vial (10mg/mL) (Additional Name of Manufacturer) 57840206T Paraplatin (carboplatin Bristol-Myers Squibb Oncology USA Third Schedule aqueous solution) Injection Bristol-Myers Squibb Company
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE 450mg per vial (10mg/mL) (Additional Name of Manufacturer) 57850206T Leukeran Tablets 2mg Heumann Pharma GmbH Germany Third Schedule (Change of Name of Manufacturer and Additional Source) 57860206T Nevipan Tablets 200mg Ranbaxy Laboratories Limited India Third Schedule (Change of Source of Bulk) 57870206 Schiff Prostate Health Distributed by Schiff Products USA Freely (Pharmacy Capsules USA (Product of USA) ONLY) Veterinary Products 57880206VP Cipdex Injection Cipla Ltd. India To Veterinarians or by Veterinary Prescription Only 57890206V Prazivet Plus Tablets Cipla Ltd. India Freely 57900206 Avagard Hand Antiseptic Made for 3M Health Care USA USA Freely Lotion with Moisturizers (Product of USA) 57910206T Amlodipina Mepha-5 Manufactured by Jaba S.A. For Portugal Third Schedule Tablets Mepha Lda. Portugal 57920206T Amlodipina Mepha-10 Genethics Pharmaceuticals Ltd. Trinidad & Third Schedule Tablets Tobago 57930206T Genprofen 800 Film-Coated Genethics Pharmaceuticals Ltd. Trinidad & Third Schedule Tablets 800mg Tobago 57940206 Genprin Enteric Coated Genethics Pharmaceuticals Ltd. Trinidad & Freely Delayed Release Tablets Tobago 81mg (Change of Colour of Tablets) Veterinary Products 57950206VP Newcastle-Bronchitis Fort Dodge Animal Health USA To Veterinarians Vaccine B1 Type, LaSota or by Veterinary Strain, Mass. Type, Live Prescription Only Virus 57960206VP Newcastle Disease Vaccine Fort Dodge Animal Health USA To Veterinarians B1 Type, B1 Strain, Live or by Veterinary Virus Prescription Only 57970206VP New Bronz Vaccine Fort Dodge Animal Health USA To Veterinarians or by Veterinary Prescription Only 57980206VP MS-Bac Vaccine Fort Dodge Animal Health USA To Veterinarians or by Veterinary Prescription Only 57990406T Diabion Capsules Manufactured by GELCAPS Mexico Third Schedule Exportadora de Mexico S.A. de C.V. For Merck S.A., de C.V. Mexico
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE 58000406T Crestor Tablets 5mg Manufactured by IPR Puerto Rico Third Schedule Pharmaceuticals Inc. For AstraZeneca UK Limited United Kingdom 58010406T Dalsan Film-Coated Tablets Egis Pharmaceuticals Ltd. Hungary Third Schedule 40mg 58020406T Mydocalm Film-Coated Gedeon Richter Ltd. Hungary Third Schedule Tablets 150mg (For Specialist Medical Practitioners Use ONLY) 58030406T Omeprazole 40mg Injection Manufactured by Meditab India Third Schedule Freeze Dried Powder For Specialities Pvt. Ltd. For Health Reconstitution with Solvent 2000 Inc. Canada For Reconstitution 58040406T Diclofenac Sodium Injection Manufactured by Meditab India Third Schedule Specialities Pvt. Ltd. For Health 2000 Inc. Canada 58050406T Methotrexate 50mg/2ml Manufactured by Meditab India Third Schedule Injection Specialities Pvt. Ltd. For Health 2000 Inc. Canada 58060406T Aprovel Tablets 150mg Manufactured by Sanofi France Third Schedule Winthrop Industrie For Sanofi Pharma Bristol-Myers Squibb SNC France 58070406T Aprovel Tablets 300mg Manufactured by Sanofi France Third Schedule Winthrop Industrie For Sanofi Pharma Bristol-Myers Squibb SNC France 58080406T CoAprovel Tablets Manufactured by Sanofi France Third Schedule 150/12.5mg Winthrop Industrie For Sanofi Pharma Bristol-Myers Squibb SNC France 58090406T CoAprovel Tablets Manufactured by Sanofi France Third Schedule 300/12.5mg Winthrop Industrie For Sanofi Pharma Bristol-Myers Squibb SNC France 58100406 Glucosamine Chondroitin Jamieson Laboratories Canada Freely MSM Caplets 1300mg 58110406 Omega 3-6-9 Capsules Jamieson Laboratories Canada Freely 58120406 Rub.A535 Pain Relieving Church & Dwight Canada Corp. Canada Freely Rub - Heat 58130406T Microvisc Solution Bohus BioTech AB Sweden Third Schedule 58140406T Hemotin-EPO 3000 Shenyang Sunshine China Third Schedule Recombinant Human Pharmaceutical Co., Ltd. Erythropoietin For Injection
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE 58150406T Hemotin-EPO 10000 Shenyang Sunshine China Third Schedule Recombinant Human Pharmaceutical Co., Ltd. Erythropoietin For Injection 58160406 Ester-C Capsules 500mg Natrol, Inc. USA Freely 58170406 My Favorite Vitamin E Natrol, Inc. USA Freely (Pharmacy Softgels 400 IU ONLY) 58180406T Artequin-300/750 Lactabs - Mepha Ltd. Switzerland Third Schedule Child 58190406T Artequin-600/1500 Lactabs Mepha Ltd. Switzerland Third Schedule - Adult 58200406T Buscopan Solution For Boehringer Ingelheim (Canada) Canada Third Schedule Injection 20mg/mL (Change Ltd. of Source of Bulk) 58210406 Esclerovitán A.O. Capsules Manufactured by Gelcaps Mexico Freely (Pharmacy (Change of Name of Exportadora de México S.A. de ONLY) Manufacturer of Dosage C.V. For Merck S.A. de C.V. Form) México 58220406T Nyolol Ophthalmic Gel Manufactured by Novartis Switzerland Third Schedule (Change of Name of Ophthalmics AG For Novartis Manufacturer) Pharma AG Switzerland 58230406 Viscotears Ophthalmic Gel Manufactured by Dr. G. Mann Germany Freely (Change of Name of Pharma For Novartis Pharma Manufacturer) AG Switzerland 58240406T Visudyne Powder For Manufactured by Parkedale USA Third Schedule Solution For Infusion 15mg Pharmaceuticals, Inc. For (Change of Name of Novartis Pharma AG Manufacturer) Switzerland 58250406T Sandoglobulin Lyophilised ZLB Behring AG Switzerland Third Schedule Powder For Intravenous Administration (Change of Name of Manufacturer)
58260406T Plavix Film-Coated Tablets Manufactured by Sanofi France Third Schedule 75mg (Additional Source, Winthrop Industrie For Sanofi Change of Packaging and Pharma Bristol-Myers Squibb Change of Presentation) SNC France 58270406T Tetagam P Solution (ready- ZLB Behring GmbH Germany Third Schedule for-use) For Intramuscular Administration (Additional Presentation) 58280406 Andrews Sparkling Salts – GlaxoSmithKline Costa Rica, Costa Rica Freely Lemon (Change of S.A. Formulation) 58290406 Duofilm Solution (Change Manufactured by Stiefel Mexico Freely of Name of Manufacturer) Mexicana, S.A. de C.V. For
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE Stiefel Laboratories, Inc. USA 58300406T Hemotin-EPO 2000 Shenyang Sunshine China Third Schedule Recombinant Human Pharmaceutical Co., Ltd. Erythropoietin For Injection (Change of Name of Manufacturer and Change of Artwork Design) 58310406T Hemotin-EPO 4000 Shenyang Sunshine China Third Schedule Recombinant Human Pharmaceutical Co., Ltd. Erythropoietin For Injection (Change of Name of Manufacturer and Change of Artwork Design) 58320406 Nutriforte Energy Formula Manufactured by DreamPak, USA Freely Drinkable Ampoules L.L.C. For Oracle Natural (Additional Source) Health British Virgin Islands 58330406T Combutol 400 Film-Coated Lupin Ltd. India Third Schedule Tablets 58340406T Trichogyl-250 Tablets Tablets (India) Limited India Third Schedule 58350406T Trichogyl-500 Tablets Tablets (India) Limited India Third Schedule 58360406 Flax Seed Oil Softgels Natrol, Inc. USA Freely (Pharmacy 1000mg ONLY) 58370406 Fitzroy Tonic Made for Fitzroy International UK Freely Ltd. UK (Product of UK) 58380406T Gliclaz M Tablets Khandelwal Laboratories Pvt. India Third Schedule Ltd. 58390406T Amlodipine Tablets 10mg Manufactured by Merck, S.A. Brasil Third Schedule For Merck, S.A. Guatemala 58400406 Infants' Mylicon Gas Relief Johnson & Johnson.Merck USA Freely Original Drops Consumer Pharmaceuticals Co. 58410406T Alphacaine 100 Injectable DFL Indústria e Comércio Ltda. Brasil Third Schedule Anesthetic 58420406T Gravol Long-Acting Caplets Church & Dwight Canada Corp. Canada Third Schedule 100mg (Immediate and Sustained Released) 58430406T Stavudine Capsules USP Aurobindo Pharma Limited India Third Schedule 40mg 58440406T Lamivudine 150mg & Aurobindo Pharma Limited India Third Schedule Zidovudine 300mg Film- Coated Tablets 58450406T Nevirapine Tablets 200mg Aurobindo Pharma Limited India Third Schedule 58460406T Efavirenz Film-Coated Aurobindo Pharma Limited India Third Schedule Tablets 600mg 58470406T Zidovudine Film-Coated Aurobindo Pharma Limited India Third Schedule Tablets USP 300mg 58480706T Apo-Brimonidine Apotex Inc. Canada Third Schedule
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE Ophthalmic Solution 0.2% w/v 58490706T Fosamax Plus Tablets Manufactured by MSD Mexico Third Schedule 70mg/2800 IU FROSST IBÈRICA, S.A. Spain Packaged by MERCK SHARP & DOHME DE MEXICO, S.A. DE C.V. 58500706 Imodium A-D Caplets Distributed by McNeil USA Freely Consumer & Specialty Pharmaceuticals DIVISION OF MCNEIL-PPC, INC. USA (Product of USA) 58510706T Tamiflu Powder for Oral Made by F. Hoffmann-La Switzerland Third Schedule Suspension 12mg/ml Roche Ltd Licenser: Gilead Sciences USA 58520706 Regular Strength ex.lax Pills Novartis Consumer Health, Inc. USA Freely 58530706 Maximum Strength ex.lax Novartis Consumer Health, Inc. USA Freely Pills 58540706 Cari Med Antiseptic Distributed by Cariba USA Freely Mouthwash - Original International Corp. USA (Product of USA) 58550706 Cari Med Antiseptic Distributed by Cariba USA Freely Mouthwash - Icy Mint International Corp. USA (Product of USA) 58560706 Cari Med Antiseptic Distributed by Cariba USA Freely Mouthwash - Citrus Fresh International Corp. USA (Product of USA) 58570706T Exifine Cream 1% w/w Dr. Reddy's Laboratories Ltd. India Third Schedule 58580706T Flexbumin 25%, Albumin Baxter Healthcare Corporation USA Third Schedule (Human), USP, 25% Solution 58590706T Actilyse 50mg Powder and Manufactured by Boehringer Germany Third Schedule Solvent for Solution for Ingelheim Pharma GmbH & Injection (Actilyse Co. KG for Boehringer Treatment - Set) Ingelheim International GmbH Germany 58600706T Levemir Penfill Solution for Novo Nordisk A/S Denmark Third Schedule Injection in a Cartridge 100U/ml 58610706T Prexige Film-Coated Tablets Novartis Pharma AG Switzerland Third Schedule 100 mg 58620706T Prexige Film-Coated Tablets Novartis Pharma AG Switzerland Third Schedule 400 mg 58630706 Vitamin B 12 Timed Release Jamieson Laboratories Canada Freely Tablets 1200 mcg
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE
58640706 Bunny's Corn & Wart Manufactured by Supreme Jamaica Freely Remover Colloidal Solution Chemicals Ltd. For Bunny Products Jamaica 58650706T Xatral LP Prolonged Release Manufacturer: Sanofi Winthrop France Third Schedule Tablets 10 mg Industrie Distributor: Sanofi- Synthelabo France 58660706T Procoralan Film-Coated Manufacturer: Les Laboratoires France Third Schedule Tablets 5 mg Servier Industrie License Holder: Les Laboratoires Servier France 58670706T Procoralan Film-Coated Manufacturer: Les Laboratoires France Third Schedule Tablets 7.5 mg Servier Industrie License Holder: Les Laboratoires Servier France 58680706T Exjade Dispersible Tablets Novartis Pharma AG Switzerland Third Schedule 125 mg 58690706T Exjade Dispersible Tablets Novartis Pharma AG Switzerland Third Schedule 250 mg 58700706T Exjade Dispersible Tablets Novartis Pharma AG Switzerland Third Schedule 500 mg 58710706T Diovan 320 Tablets Packaged by Novartis Brazil Third Schedule Biociências S.A. 58720706 Robitussin Cough & Cold Wyeth Consumer Healthcare USA Freely CF Non-Drowsy Cold Formula (Alcohol-Free) (Change of Name of Product, Change of Formulation and Change of Artwork Design) 58730706 Children's Dimetapp Cold & Wyeth Consumer Healthcare USA Freely Allergy Elixir - Yummy Grape Taste (Alcohol-Free) (Change of Formulation and Change of Artwork Design) 58740706 Children's Dimetapp DM Wyeth Consumer Healthcare USA Freely Cold & Cough Elixir - Great Red Grape Taste (Alcohol- Free) (Change of Formulation) 58750706 Tylenol Allergy Multi- Distributed by McNeil USA Freely Symptom Cool Burst Consumer & Specialty Caplets (Change of Name of Pharmaceuticals DIVISION OF Product, Change of MCNEIL-PPC, INC. USA Formulation and Labelling (Product of USA) Changes) 58760706 Tylenol Cold Head Distributed by McNeil USA Freely
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE Congestion Severe Daytime Consumer & Specialty Non-Drowsy Cool Burst Pharmaceuticals DIVISION OF Caplets (Change of Name of MCNEIL-PPC, INC. USA Product, Change of (Product of USA) Formulation and Labelling Changes)
58770706 Tylenol Sinus Congestion & Distributed by McNeil USA Freely Pain Daytime Non-Drowsy Consumer & Specialty Cool Burst Caplets (Change Pharmaceuticals DIVISION OF of Name of Product, MCNEIL-PPC, INC. USA Change of Formulation and (Product of USA) Labelling Changes) 58780706 Tylenol Sinus Congestion & Distributed by McNeil USA Freely Pain Severe Daytime Non- Consumer & Specialty Drowsy Cool Burst Caplets Pharmaceuticals DIVISION OF (Change of Formulation) MCNEIL-PPC, INC. USA (Product of USA) 58790706T Eltroxin Tablets 50mcg Glaxo Wellcome GmbH & Co. Germany Third Schedule (Change of Formulation) 58800706T Eltroxin Tablets 100mcg Glaxo Wellcome GmbH & Co. Germany Third Schedule (Change of Formulation) 58810706T Tarceva Film-Coated Made under licence from F. USA Third Schedule Tablets 25mg (Additional Hoffmann-La Roche Ltd Indication) Switzerland by Schwarz Pharma Manufacturing Inc 58820706T Tarceva Film-Coated Made under licence from F. USA Third Schedule Tablets 100mg (Additional Hoffmann-La Roche Ltd Indication) Switzerland by Schwarz Pharma Manufacturing Inc 58830706T Tarceva Film-Coated Made under licence from F. USA Third Schedule Tablets 150mg (Additional Hoffmann-La Roche Ltd Indication) Switzerland by Schwarz Pharma Manufacturing Inc 58840706 Vit-B-Denk Film-Coated DENK PHARMA GmbH & Germany Freely Tablets (Change of Name of Co. KG Manufacturer) 58850706T Nifedi-Denk 10 Retard DENK PHARMA GmbH & Germany Freely Tablets (Change of Name of Co. KG Manufacturer) 58860706T Nifedi-Denk 20 Retard DENK PHARMA GmbH & Germany Third Schedule Tablets (Change of Name of Co. KG Manufacturer) 58870706T Metformin Denk 500 f.c. DENK PHARMA GmbH & Germany Third Schedule Tablets (Change of Name of Co. KG Manufacturer) 58880706T Metformin Denk 850 f.c. DENK PHARMA GmbH & Germany Third Schedule
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE Tablets (Change of Name of Co. KG Manufacturer) 58890706T Diclo-Denk 75 Injection DENK PHARMA GmbH & Germany Third Schedule (Change of Name of Co. KG Manufacturer)
58900706T Acyclovir Denk 200 Tablets DENK PHARMA GmbH & Germany Third Schedule (Change of Name of Co. KG Manufacturer and Change of Artwork Design) 58910706T Clotri-Denk 100 Vaginal DENK PHARMA GmbH & Germany Third Schedule Tablets with Applicator Co. KG (Change of Name of Manufacturer and Change of Artwork Design) 58920706 Paracetamol Denk 125 Manufactured by RubiePharm Germany Freely Suppos Suppositories Arzneimittel GmbH for DENK (Change of Name of PHARMA GmbH & Co. KG Manufacturer) Germany 58930706 Paracetamol Denk 250 Manufactured by RubiePharm Germany Freely Suppos Suppositories Arzneimittel GmbH for DENK (Change of Name of PHARMA GmbH & Co. KG Manufacturer) Germany 58940706T Levemir FlexPen Solution Novo Nordisk A/S Denmark Third Schedule for Injection in a Pre-Filled Pen 100U/ml (Additional Presentation) 58950706T NovoRapid FlexPen Novo Nordisk A/S Denmark Third Schedule Solution for Injection in a Pre-Filled Pen 100U/ml (Additional Presentation) 58960706T Trental Sugar-Coated Aventis Pharma S.A. Venezuela Third Schedule Tablets 400mg (Additional Source) 58970706T Alesse 28 Tablets Wyeth Canada Canada Third Schedule (Additional Indication, Additional Source and Additional Artwork Design) 58980706T Leponex Tablets 25 mg Manufactured by Novartis Great Britain Third Schedule (Additional Indication) Pharmaceuticals UK Ltd for Novartis Pharma AG Switzerland 58990706T Leponex Tablets 100 mg Manufactured by Novartis Great Britain Third Schedule (Additional Indication) Pharmaceuticals UK Ltd for Novartis Pharma AG
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE Switzerland Veterinary Product 59000706VP Protektor Spray 0.25% w/v Cipla Ltd. India To Veterinarians or by Veterinary Prescription Only 59010906 Motrin IB Coated Caplets Distributed by: McNeil USA Freely USP 200mg Consumer & Specialty Pharmaceuticals DIVISION OF MCNEIL-PPC, INC. USA (Product of USA)
59020906T Cortaid Intensive Therapy Distributed by: Johnson & USA Third Schedule Moisturizing Anti-Itch Johnson Consumer Products Cream Company Division of Johnson & Johnson Consumer Companies, Inc. USA (Product of USA) 59030906T Cortaid Advanced Long- Distributed by: Johnson & USA Third Schedule Lasting Anti-Itch Hand Johnson Consumer Products Cream Company Division of Johnson & Johnson Consumer Companies, Inc. USA (Product of USA) 59040906T Lobevat Ointment Stiefel Mexicana, S.A. de C.V. Mexico Third Schedule 59050906T Lobevat Cream Stiefel Mexicana, S.A. de C.V. Mexico Third Schedule 59060906T Lobevat Gel Stiefel Mexicana, S.A. de C.V. Mexico Third Schedule 59070906T Humalog Mix 75/25 Eli Lilly and Company USA Third Schedule Injection 59080906T Invanz 1g Powder for Manufactured by: Laboratories France Third Schedule Concentrate for Solution for Merck Sharp & Dohme-Chibret Infusion for Merck & Co., Inc. USA 59090906T Depakote ER Extended- Manufactured by: Abbott Puerto Rico Third Schedule Release Tablets 250mg Pharmaceuticals PR Ltd. For Abbott Laboratories USA 59100906 Nexcare Moisturizing Hand Made for:3M Consumer Health USA Freely Sanitizer Care USA (Product of USA) 59110906T Lamisil 1 Film Forming Novartis Consumer Health SA Switzerland Third Schedule Solution 59120906T Biosulin 30/70 Suspension M.J. Biopharm Private Limited India Third Schedule for Injections 100IU/ml 59130906T Biosulin L Suspension for M.J. Biopharm Private Limited India Third Schedule Injections 100IU/ml 59140906T Biosulin N Suspension for M.J. Biopharm Private Limited India Third Schedule Injections 100IU/ml 59150906T Biosulin R Solution for M.J. Biopharm Private Limited India Third Schedule
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE Injections 100IU/ml 59160906 Haliborange High DHA Made for Seven Seas Health England Freely Concentration Omega-3 Care Ltd. England (Product of Fish Oil Orange Flavour England) Chewy Fruit Burst Capsules For Kids 59170906 Haliborange High DHA Made for Seven Seas Health England Freely Concentration Omega-3 Care Ltd. England (Product of Fish Oil Blackcurrant Chewy England) Fruit Burst Capsules For Kids 59180906T Tritace Tablets 2.5mg Aventis Pharma S.A. Venezuela Third Schedule (Additional Source and Change of Artwork Design) 59190906T Tritace Tablets 5mg Aventis Pharma S.A. Venezuela Third Schedule (Additional Source and Change of Artwork Design)
59200906T Batrafen Cream (Additional Aventis Pharma S.A. Venezuela Third Schedule Source and Change of Artwork Design) 59210906T Batrafen Solution Aventis Pharma S.A. Venezuela Third Schedule (Additional Source and Change of Artwork Design) 59220906T Lasix Tablets 40mg Aventis Pharma S.A. Venezuela Third Schedule (Additional Source and Change of Artwork Design) 59230906T Daonil Tablets 5mg Aventis Pharma S.A. Venezuela Third Schedule (Additional Source and Change of Artwork Design) 59240906T Lantus Injectable Solution Aventis Pharma Germany Third Schedule 100IU/mL-Vial (Change of Formulation) 59250906 Tylenol Cold Multi- Distributed by: McNeil USA Freely Symptom Daytime Non- Consumer & Specialty Drowsy Cool Burst Caplets Pharmaceuticals DIVISION OF (Change of Formulation) MCNEIL-PPC, INC. USA (Product of USA) 59260906 Tarmed Shampoo (Change Stiefel Mexicana, S.A. de C.V. Mexico Freely of Name of Manufacturer and Change of Source) 59270906 PanOxyl Bar 5 (Change of Stiefel Mexicana, S.A. de C.V. Mexico Freely Name of Manufacturer and Change of Source) 59280906 PanOxyl Bar 10 (Change of Stiefel Mexicana, S.A. de C.V. Mexico Freely Name of Manufacturer and Change of Source)
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE 59290906 Prurix Lotion (Change of Stiefel Mexicana, S.A. de C.V. Mexico Freely Name of Manufacturer and Change of Source) 59300906T Captopril + HCT Denk DENK PHARMA GmbH & Germany Third Schedule 50/25 Tablets (Change of Co. KG Name of Manufacturer and Change of Artwork Design) 59310906T Atenolol Denk 50 f.c. DENK PHARMA GmbH & Germany Third Schedule Tablets (Change of Name of Co. KG Manufacturer and Change of Artwork Design) 59320906 Para-Denk 500 Tablets Manufactured by: bene- Germany Freely (Change of Name of Arzneimittel GmbH For Manufacturer) DENK PHARMA GmbH & Co. KG Germany 59330906 Para-Denk 4% Syrup Manufactured by: bene- Germany Freely (Change of Name of Arzneimittel GmbH For Manufacturer) DENK PHARMA GmbH & Co. KG Germany 59350906 Redoxon Vitamin C 1g Made by: Syntex, S.A. de C.V. Mexico Freely Effervescent Tablets - For Bayer de Mexico, S.A. de Orange Flavour (Change of C.V. Mexico Name of Declared Licence Holder) 59360906 Redoxon forte Vitamin C 2g Made by: Syntex, S.A. de C.V. Mexico Freely Effervescent Tablets - For Bayer de Mexico, S.A. de Lemon Flavour (Change of C.V. Mexico Name of Declared Licence Holder) 59370906 Redoxon Vitamin C 500mg Bayer S.A. Argentina Freely Chewable Tablets – Tangerine (Change of Name of Manufacturer) 59380906 Systane free Liquid Gel Alcon Laboratories, Inc. USA Freely Lubricant Eye Drops (Change of Name of Product and Change of Formulation) 59390906T Zovirax Tablets 200mg GlaxoSmithKline Mèxico, S.A. Mexico Third Schedule (Change of Name of de C.V. Manufacturer and Change of Source) 59400906T Zovirax Tablets 400mg GlaxoSmithKline Mèxico, S.A. Mexico Third Schedule (Change of Name of de C.V. Manufacturer and Change of Source) 59410906T Acyclovir Denk 5% Cream Manufactured for: DENK Germany Third Schedule
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE (Change of Name of PHARMA GmbH & Co. KG Manufacturer and Change of Germany (Product of Germany) Artwork Design) 59420906 Clotri-Denk 1% Cream Manufactured by: RubiePharm Germany Freely (Change of Name of Arzneimittel GmbH For Manufacturer and Change of DENK PHARMA GmbH & Artwork Design) Co. KG Germany 59430906 Tylenol Cold Multi- Distributed by: McNeil USA Freely Symptom Severe Daytime Consumer & Specialty Non-Drowsy Cool Burst Pharmaceuticals DIVISION OF Caplets (Change of MCNEIL-PPC, INC. USA Formulation) (Product of USA) 59440906 Tylenol Chest Congestion Distributed by: McNeil USA Freely Daytime Non-Drowsy Cool Consumer & Specialty Burst Caplets (Change of Pharmaceuticals DIVISION OF Formulation) MCNEIL-PPC, INC. USA (Product of USA) 59450906 Tylenol Cold Head Distributed by: McNeil USA Freely Congestion Daytime Non- Consumer & Specialty Drowsy Cool Burst Caplets Pharmaceuticals DIVISION OF (Change of Formulation) MCNEIL-PPC, INC. USA (Product of USA)
59460906 Tylenol Severe Allergy Distributed by: McNeil Canada Freely Caplets (Change of Artwork Consumer & Specialty Design) Pharmaceuticals DIVISION OF MCNEIL-PPC, INC. USA Veterinary Product 59470906VP Avinew Live Vaccine against Merial France To Veterinarians Newcastle diseases VG/GA or by Veterinary Strain - Freeze dried pellets Prescription Only 59481206 Children's Tylenol Plus Distributed by McNeil USA Freely Cough & Runny Nose Oral Consumer & Specialty Suspension - Cherry Flavor Pharmaceuticals DIVISION OF MCNEIL-PPC, INC. USA (Product of USA) 59491206 Children's Tylenol Plus Distributed by McNeil USA Freely Cough & Sore Throat Oral Consumer & Specialty Suspension - Cherry Flavor Pharmaceuticals DIVISION OF MCNEIL-PPC, INC. USA (Product of USA) 59501206T Ocutim Eye Drops 0.5% Cipla Ltd. India Third Schedule 59511206 Women's Panadol Caplets GlaxoSmithKline Panamá, S.A. Panama Freely 59521206 Children Gravol Quick Church & Dwight Canada Corp. Canada Freely Dissolve Chewable Tablets
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE 15mg - Cherry Flavour 59531206 Adults Gravol Quick Church & Dwight Canada Corp. Canada Freely Dissolve Chewable Tablets 50mg - Orange Flavour 59541206T Proviron Tablets 25mg Schering do Brasil, Química e Brazil Third Schedule (Change of Name of Farmacêutica Ltda Manufacturer, Change of Source, Change of Packaging and Change of Artwork Design) 59551206T Climene Tablets (Additional Schering do Brasil, Química e Brazil Third Schedule Manufacturing Site) Farmacêutica Ltda 59561206T Vera-Denk 240 Retard DENK PHARMA GmbH & Germany Third Schedule Tablets (Change of Name of Co. KG Manufacturer) 59571206 Denkalgin pain relief Tablets DENK PHARMA GmbH & Germany Freely (Change of Name of Co. KG Manufacturer) 59581206T Diclo-Denk 100 Retard DENK PHARMA GmbH & Germany Third Schedule Tablets (Change of Name of Co. KG Manufacturer) 59591206T Rani-Denk 150 Film-Coated DENK PHARMA GmbH & Germany Third Schedule Tablets (Change of Name of Co. KG Manufacturer) 59601206T Captopril Denk 25 Tablets DENK PHARMA GmbH & Germany Third Schedule (Change of Name of Co. KG Manufacturer) 59611206 Savlon Antiseptic Liquid Manufactured by Genethics Trinidad and Freely (Change of Packaging and Pharmaceuticals Ltd. Tobago Change of Artwork Design) Distributed by J & J (T’dad) Ltd. Trinidad and Tobago 59621206 Robitussin Head & Chest Wyeth Consumer Healthcare USA Freely Congestion PE Non- Drowsy Expectorant (Liquid Congestion Formula) - Adults & Children (Alcohol - Free) (Change of Name of Product, Change of Formulation and Change of Artwork Design) 59631206 Robitussin Pediatric Cough Wyeth Consumer Healthcare USA Freely & Cold Nighttime Liquid Cold Formula - Children (Fruit Punch Flavor) (Alcohol - Free) (Change of Name of Product, Change of Formulation and Change
DAN TRADE NAME AND MANUFACTURER COUNTRY CONDITION FORM OF ORIGIN OF SALE of Artwork Design) 59641206 Robitussin Pediatric Cough Wyeth Consumer Healthcare USA Freely & Cold Long-Acting Liquid Cold Formula - Children (Fruit Punch Flavor) (Alcohol - Free) (Change of Name of Product, Change of Formulation and Change of Artwork Design) 59651206C Frisium Tablets 10mg Aventis Pharma S.A. Venezuela Controlled Drug (Additional Source and Change of Artwork Design) 59661206T Batrafen Vaginal Cream with Aventis Pharma S.A. Venezuela Third Schedule Disposable Applicators (Additional Source and Change of Artwork Design) 59671206T Cataflam Injectable Solution Novartis Farmacèutica, S.A. de Mexico Third Schedule 75mg/3ml (Additional C.V. Source)