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Active Ingredient Dosage Strength and Form Comparator Drug1 Marketing Authorization Holder [Manufacturer] Registration Number A

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Active Ingredient Dosage Strength and Form Comparator Drug1 Marketing Authorization Holder [Manufacturer] Registration Number A Republic of the Philippines Department of Health FOOD AND DRUG ADMINISTRATION CENTER FOR DRUG REGULATION AND RESEARCH Provisional List of Comparator Products for in vivo and/or in vitro Equivalence Studies (as of 11 July 2019) Active Ingredient Dosage Strength Comparator Marketing Registration and Form Drug1 Authorization Holder Number [Manufacturer] Abacavir (as sulfate) 300mg Tablet ZIAGEN ViiV Healthcare UK Ltd.2 Not available ViiV Healthcare Co.3 locally Abacavir (as sulfate) 600mg/300mg KIVEXA ViiV Healthcare UK Ltd.2 Not available + Lamivudine Tablet EPZICOM ViiV Healthcare Co.3 locally Abacavir (as sulfate) 300mg/150mg/30 TRIZIVIR ViiV Healthcare UK Ltd.2 Not available + Lamivudine + 0mg Tablet ViiV Healthcare Co.3 locally Zidovudine Abacavir (as sulfate) 600mg/50mg/300 TRIUMEQ ViiV Healthcare UK Ltd.2 Not available + Dolutegravir (as mg Tablet ViiV Healthcare Co.3 locally sodium) + Lamivudine Abiraterone Acetate 250mg Tablet ZYTIGA Johnson & Johnson DR-XY41696 (Phils.), Inc. [Patheon Inc. – Canada] 500mg Tablet ZYTIGA Janssen-Cilag Ltd.2 Not available Janssen Biotech Inc.3 locally Acarbose 25mg Tablet PRECOSE Bayer Healthcare Not available Pharmaceuticals Inc.3 locally 50mg Tablet GLUCOBAY Bayer Philippines, Inc. DRP-3657 [Bayer Pharma AG – Germany] 100mg Tablet GLUCOBAY Bayer Philippines, Inc. DRP-3658 [Bayer Pharma AG – Germany] Aceclofenac 100 mg Film- PRESERVEX Almirall Limited – UK2 Not available Coated Tablet locally Acetazolamide 250 mg Tablet DIAMOX Wyeth Phils., Inc. [Wyeth DR-2928 Lederle Ltd. – India] Acetylcysteine Capsule Available orally administered dosage forms of the comparator Powder or product/reference drug (FLUIMUCIL of The Cathay Drug Co., Granules for Oral Inc. manufactured by Zambon Switzerland Ltd.) are in Suspension effervescent tablet and powder or granules for oral solution. In this regard, provide in vivo or in vitro equivalence evidence, whichever is applicable, using a comparator in the same dosage form purchased from a country participating in the International Civic Drive, Filinvest City, Alabang 1781 Muntinlupa City, Philippines Trunk Line +63 2 857 1900 Fax +63 2 807 0751 Website: www.fda.gov.ph Email: [email protected] 1 Council for Harmonization (ICH). Documentary proof of purchase should be provided. Acetylsalicylic Acid 30 mg Tablet COR-30 Pascual Labs., Inc. DR-XY17534 (Aspirin) [Pascual Labs., Inc.] 80 mg Tablet ASPILETS LR Imperial, Inc. [Amherst DR-2350 Labs., Inc.] 100 mg Tablet BAYER Bayer Phils., Inc. [Bayer DRGDA ASPIRIN Bitterfeld GmbH – 00000002 Germany] 300 mg Tablet BAYER Bayer Phils., Inc. [Bayer DR-XY35870 ASPIRIN Bitterfeld GmbH – Germany] 325 mg Tablet Unbranded Philusa Corp. [Amherst DR-5053 Labs., Inc.] 100 mg Enteric- BAYPRIN EC Bayer Phils., Inc. [Bayer DR-XY23747 coated Tablet Pharma AG – Germany] Aciclovir 200 mg Tablet ZOVIRAX GlaxoSmithKline Phils., DR-XY2013 Inc. [Glaxo Wellcome S.A. – Spain] 400 mg Tablet ZOVIRAX GlaxoSmithKline Phils., DR-XY8177 Inc. [Glaxo Wellcome S.A. – Spain] 800 mg Tablet ZOVIRAX GlaxoSmithKline Phils., DR-XY19137 Inc. [Glaxo Wellcome S.A. – Spain] 200 mg/5 mL Oral ZOVIRAX GlaxoSmithKline UK2 Not available Suspension Mylan Pharmaceuticals, locally Inc.3 Acitretin 10mg Capsule NEOTIGASON Pascual Pharma DR-XY13978 Corporation [Patheon Inc. – Canada] 17.5mg Capsule SORIATANE Stiefel Laboratories Inc.3 Not available locally 22.5mg Capsule SORIATANE Stiefel Laboratories Inc.3 Not available locally 25mg Capsule NEOTIGASON Actavis UK Ltd.2 Not available SORIATANE Stiefel Laboratories Inc.3 locally Adefovir Dipivoxil 10mg Tablet HEPSERA GlaxoSmithKline DR-XY29597 Philippines Inc. [GlaxoSmithKline (Tianjin) Co. Ltd. – China] Afatinib (as 20mg Tablet GIOTRIF Boehringer Ingelheim DR-XY43779 Dimaleate) (Phil.) Inc. [Boehringer Ingelheim Pharma GmbH & Co. KG – Germany] 30mg Tablet GIOTRIF Boehringer Ingelheim DR-XY43780 (Phil.) Inc. [Boehringer 2 Ingelheim Pharma GmbH & Co. KG – Germany] 40mg Tablet GIOTRIF Boehringer Ingelheim DR-XY43782 (Phil.) Inc. [Boehringer Ingelheim Pharma GmbH & Co. KG – Germany] 50mg Tablet GIOTRIF Boehringer Ingelheim DR-XY43781 (Phil.) Inc. [Boehringer Ingelheim Pharma GmbH & Co. KG – Germany] Agomelatine 25 mg Film- VALDOXAN Servier Phils., Inc. [Les DR-XY41362 Coated Tablet Laboratoires Servier Industrie – France] Albendazole 400 mg Chewable ZENTEL GlaxoSmithKline Phils., DR-XY13050 Tablet Inc. [SmithKline Beecham (Phils.)] 200 mg/5 mL Oral ZENTEL GlaxoSmithKline Phils., DR-XY21457 Suspension Inc. [SmithKline Beecham (Phils.)] Alendronic Acid (as 70 mg Tablet FOSAMAX Merck Sharp & Dohme DR-XY27118 Alendronate sodium) (I.A.) Corp. [Merck Sharp & Dohme (Italia) S.p.A. – Italy] Alendronic Acid (as 70 mg/2,800 IU FOSAVANCE Merck Sharp & Dohme DR-XY31364 Alendronate sodium) Tablet (I.A.) Corp. [Frosst Iberica + Cholecalciferol S.A. – Spain] (Vitamin D3) 70 mg/5,600 IU FOSAVANCE Merck Sharp & Dohme DRP-5860 Tablet (I.A.) Corp. [Frosst Iberica (DR-XY35366) S.A. – Spain] Alfuzosin 2.5 mg Tablet XATRAL Sanofi-Aventis Phils., Inc. DRP-191 hydrochloride [Sanofi-Winthrop Industrie S.A. – France] 5 mg Sustained- XATRAL SR Sanofi-Aventis Phils., Inc. DR-XY23216 release Tablet [Sanofi-Winthrop Industrie S.A. – France] 10 mg Sustained- XATRAL OD Sanofi-Aventis Phils., Inc. DRP-072 release Tablet [Sanofi-Winthrop Industrie S.A. – France] Aliskiren (as 150mg Tablet RASILEZ Novartis Healthcare Phils., DR-XY33881 hemifumarate) Inc. [Novartis Farma S.p.A. – Italy] 300mg Tablet RASILEZ Novartis Healthcare Phils., DR-XY33880 Inc. [Novartis Farmaceutica S.A. – Italy] Aliskiren (as 150mg/5mg RASILAMLO Novartis Healthcare Phils., DR-XY42035 hemifumarate) + Tablet Inc. [Novartis Pharma Stein AG – Switzerland] 3 Amlodipine (as 300mg/5mg RASILAMLO Novartis Healthcare Phils., DR-XY42034 besilate) Tablet Inc. [Novartis Pharma Stein AG – Switzerland] Aliskiren (as 150mg/12.5mg RASILEZ HCT Novartis Not available hemifumarate) + Tablet TEKTURNA Noden Pharma DAC3 locally Hydrochlorothiazide HCT 150mg/25mg RASILEZ HCT Novartis Not available Tablet TEKTURNA Noden Pharma DAC3 locally HCT 300mg/12.5mg RASILEZ HCT Novartis Not available Tablet TEKTURNA Noden Pharma DAC3 locally HCT 300mg/25mg RASILEZ HCT Novartis Not available Tablet TEKTURNA Noden Pharma DAC3 locally HCT Allopurinol 100 mg Tablet ZYLOPRIM Aspen Phils., Inc. [Aspen DR-273 Bad Oldesloe GmbH – Germany] 300 mg Tablet ZYLOPRIM Aspen Phils., Inc. [Aspen DR-10173 Bad Oldesloe GmbH – Germany] Alogliptin (as 6.25 mg Tablet VIPIDIA Takeda UK Ltd.2 Not available benzoate) NESINA Takeda Pharmaceuticals locally USA Inc.3 12.5 mg Tablet VIPIDIA Takeda UK Ltd.2 Not available NESINA Takeda Pharmaceuticals locally USA Inc.3 25 mg Tablet VIPIDIA Takeda UK Ltd.2 Not available NESINA Takeda Pharmaceuticals locally USA Inc.3 Alogliptin (as 12.5 mg/500 mg VIPDOMET Takeda UK Ltd.2 Not available benzoate) + Tablet KAZANO Takeda Pharmaceuticals locally Metformin USA Inc.3 hydrochloride 12.5 mg/1g Tablet VIPDOMET Takeda UK Ltd.2 Not available KAZANO Takeda Pharmaceuticals locally USA Inc.3 Alogliptin (as 12.5 mg/15 mg OSENI Takeda Healthcare Phils., DR-XY45782 benzoate) + Tablet Inc. [Takeda Pharm’l Co., Pioglitazone Ltd. Osaka Plant – Japan] hydrochloride 12.5 mg/30 mg OSENI Takeda Healthcare Phils., DR-XY45783 Tablet Inc. [Takeda Pharm’l Co., Ltd. Osaka Plant – Japan] 12.5 mg/45 mg OSENI Takeda Pharmaceuticals Not available Tablet USA Inc.3 locally 25 mg/15 mg OSENI Takeda Healthcare Phils., DR-XY45784 Tablet Inc. [Takeda Pharm’l Co., Ltd. Osaka Plant – Japan] 4 25 mg/30 mg OSENI Takeda Healthcare Phils., DR-XY45785 Tablet Inc. [Takeda Pharm’l Co., Ltd. Osaka Plant – Japan] 25 mg/45 mg OSENI Takeda Pharmaceuticals Not available Tablet USA Inc.3 locally Alprazolam 250mcg Tablet XANOR Pfizer Inc. [Sanico NV – DRP-2146 Belgium] 500mcg Tablet XANOR Pfizer Inc. [Pfizer DR-XY14607 Pharmaceutical LLC – Puerto Rico] 1mg Tablet XANOR Pfizer Inc. [Pfizer DR-XY16774 Pharmaceutical LLC – Puerto Rico] 2mg Tablet XANAX Pharmacia and Upjohn Not available Co.3 locally 500mcg XANOR XR Pfizer Inc. [Sanico NV – DRP-2048 Controlled- Belgium] Release Tablet 1mg Controlled- XANAX XR Pharmacia and Upjohn3 Not available /Extended-Release locally Tablet 2mg Controlled- XANAX XR Pharmacia and Upjohn3 Not available Release Tablet locally 3mg Controlled- XANAX XR Pharmacia and Upjohn3 Not available Release Tablet locally Alverine Citrate 60mg Capsule SPASMONAL Meda Pharmaceuticals2 Not available locally 120mg Capsule SPASMONAL Meda Pharmaceuticals2 Not available FORTE locally Ambrisentan 5mg Tablet VOLIBRIS GlaxoSmithKline DR-XY39400 Philippines, Inc. [Patheon Inc. – Canada] 10mg Tablet VOLIBRIS GlaxoSmithKline UK2 Not available Gilead Sciences Inc.3 locally Ambroxol 15 mg Lozenge STREPSILS Zuellig Pharma Corp. DR-XY34819 hydrochloride CHESTY [Reckitt Benckiser COUGH Healthcare Manufacturing (Thailand) Ltd. – Thailand] STREPSILS Zuellig Pharma Corp. DR-XY42567 CHESTY [Reckitt Benckiser COUGH Healthcare Manufacturing (Thailand) Ltd. – Thailand] 20 mg Lozenge MUCOANGIN Boehringer Ingelheim DR-XY33181 (Phil.), Inc. [Delpharm Reims S.A.S. – France] 5 30 mg Tablet MUCOSOLVAN Boehringer Ingelheim DR-XY145 (Phil.), Inc. [Interphil Labs., Inc.] MUCOSOLVAN Boehringer Ingelheim DR-XY41618 (Phil.), Inc. [Boehringer Ingelheim Pharma GmbH & Co. KG – Germany] ZOBRIXOL Natrapharm, Inc. [Hizon DR-XY5348 Labs., Inc.] MYRACOF Medichem Pharm’ls, Inc. DR-XY15803 [Amherst Labs., Inc.] AMBROLEX GlaxoSmithKline Phils., DRP-4352 Inc. [SmithKline Beecham] (DR-XY21034) 75 mg Sustained- MUCOSOLVAN Boehringer Ingelheim DR-XY18553 Release (Retard) (Phil.), Inc.
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