Content specific to this active ingredient… Drug Information Prescribing and patient information from leading authorities Drug Master Files Type 2 master files on file at the FDA Safety Information For prescription drugs containing this active ingredient Exclusivity Patent and market exclusivity data Federal Register FR search results for this API FDA Approved Labelling Information found in this drug's package inserts Research Links Chemical identification and research citations Title 21 Code of Federal Regulations FDA regulations for this API

FDA Approval Activities for this Drug… Cozaar (losartan potassium) Tablets, Merck & Co., NDA 20-386/S032 3/25/03 4/1/03 4/1/03 7/8/03 | Cozaar (losartan potassium) Tablets, 25, 50, & 100 mg, Merck & Co., NDA 20-386/S028 9/17/02 9/20/02 9/17/02 2/4/03 | Cozaar (losartan potassium) Tablets, 25, 50, & 100 mg; Hyzaar (losartan potassium / hydrochlorothiazide) Tablets, 50-12.5 & 100-25 Merck & Co., NDA 20-386/S020 & 20-387/S017 1/19/00 6/6/01 | Cozaar (losartan potassium) Tablets, 25, 50, & 100 mg; Hyzaar (losartan potassium / hydrochlorothiazide) Tablets, 50-12.5 & 100-25 Merck & Co., NDA 20-386/S018 & 20-387/S014 1/28/00 6/6/01 | Cozaar (losartan potassium) Tablets, 25 & 50 mg Merck Research NDA 20-386/S-015 11/24/98 3/13/00 | Cozaar (losartan potassium) Tablets, 25 & 50 mg Merck Research NDA 20-386/S-008 10/13/98 9/14/01 | Cozaar (losartan potassium) Tablets, 25 & 50 mg Merck & Co. NDA 20-386/S-017 Hyzaar (losartan potassium/hydrochlorothiazide), Merck & Co., NDA 20-387/S-013 & S-015 & | S-027 9/30/03 10/10/03 10/10/03 | Hyzaar (losartan potassium/hydrochlorothiazide) Tablets, 50/12.5 and 100/25 mg. Merck & Co., NDA 20-387/S-024 11/7/02 11/18/02 | Hyzaar (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg Merck Research NDA 20-387/S6 8/24/98 12/3/01 | Hyzaar (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg Merck Research NDA 20-387/S8 11/10/98 12/3/01 | Hyzaar 50-12.5 (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg Merck Research NDA 20-387/S10 8/25/98 12/3/01 | Hyzaar 50 (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg Merck Research NDA 20-387/S-011 11/24/98 3/13/00 | Hyzaar 50 (losartan potassium/hydrochlorothiazide) Tablets, 50-12.5 mg & 100-25 mg Merck Research NDA 20-387/S-012 Cozaar (losartan potassium) Tablets, Merck and Co., Inc. | Hyzaar (losartan potassium-hydrochlorothiazide) Tablets, Merck & Co., Efficacy Supplement w/Clinical Data Support | Cozaar (losartan potassium) Tablets, Merck & Co., Labeling Revision | Hyzaar (losartan potassium-hydrochlorothiazide) Tablets, Merck & Co., Labeling Revision | HYZAAR (losartan/potassium hydrochlorothiazide) Tablets, Merck Research, New Dosage Regimen | COZAAR (losartan potassium) Tablets, Merck Research, Labeling Revision | HYZAAR (losartan potassium hydrochlorothiazide) Tablets, Merck Research, Labeling Revision | Losartan Potassium Tablets, Roxane Labs, Tentative Approval | Losartan Potassium Tablets, Teva Pharma, Tentative Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Teva Pharma, Tentative Approval | Losartan Potassium & Hydrochlorothiazide Tablets, Roxane Labs, Tentative Approval | Losartan Potassium & Hydrochlorothiazide Tablets, Roxane Labs, Tentative Approval | Cozaar Tablet, Merck, Labeling Revision | Hyzaar Tablet, Merck, Labeling Revision | Cozaar (losartan potassium) Tablets, Merck & Co., Labeling Revision | Hyzaar (losartan potassium/hydrochlorothiazide) Tablets, Merck Research Labs, Labeling Revision | Losartan Potassium Tablets, Zydus Pharma, Tentative Approval | Losartan Potassium Tablets, Lek Pharma, Tentative Approval | Losartan Potassium and Hydrochlorothiazide Tablets, TEVA Pharma, Tentative Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Lek Pharma, Tentative Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Zydus Pharma, Tentative Approval | Losartan Potassium Tablets, Aurobindo Pharma, Ltd., Tentative Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Tentative Approval | Cozaar (losartan potassium) Tablets, Merck & Co., Inc., Labeling Revision | Losartan Potassium and Hydrochlorothiazide Tablets, Apotex Inc., Tentative Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Approval | Losartan Potassium Tablets, Upsher-Smith Laboratories, Inc., Tentative Approval | Losartan Potassium Tablets, Teva Pharmaceuticals USA, Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Teva Pharmaceuticals USA, Approval | Losartan Potassium Tablets, Torrent Pharmaceuticals Ltd., Tentative Approval | Losartan (losartan potassium) Tablets, Roxane Laboratories, Inc., Tentative Approval | Losartan Potassium Tablets, Zydus Pharmaceuticals, Inc., Tentative Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Lupin Limited, Tentative Approval and Approval | Losartan Potassium Tablets, Lupin Pharmaceuticals, Inc., Tentative Approval | Losartan Potassium Tablets, Actavis, Inc., Tentative Approval | Losartan Potassium Tablets, Apotex, Inc., Tentative Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Apotex, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Sandoz, Inc., Approval | Cozaar (losartan potassium) Tablets, Merck and Company, Labeling Revision | Hyzaar (losartan potassium and hydrochlorothiazide) Tablets, Merck and Company, Labeling Revision | Losartan Postassium Tablets, Actavis, Inc., Approval | Losartan Potassium Tablets, Lupin Pharmaceuticals, Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Sandoz, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Aurobindo Pharma Limited, Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Lupin Limited, Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Torrent Pharmaceuticals, Approval | Losartan (losartan potassium) Tablets, Roxane Laboratories, Inc., Approval | Losartan Potassium Tablets, Mylan Pharmaceuticals, Inc., Approval | Losartan Potassium Tablets, Sandoz Inc., Approval | Losartan Potassium Tablets, Watson Laboratories, Inc., Approval | Losartan Potassium Tablets, Apotex Corp., Approval | Losartan Potassium Tablets, Aurobindo Pharma, Approval | Losartan Potassium Tablets, Alembic Limited, Approval | Losartan Potassium Tablets, Zydus Pharmaceuticals Inc., Approval | Losartan Potassium Tablets, Upsher-Smith Laboratories, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Zydus Pharmaceuticals, Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Roxane Laboratories, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Apotex, Inc., Approval | Losartan Potassium and Hydrochlorothiazide Tablets, Watson Laboratories, Inc, Approval | Losartan Potassium Tablets, Huahai US Inc., Approval | Hyzaar (losartan potassium and hydrochlorothiazide) Tablets, Merck, Labeling Revision | Cozaar (losartan potassium) Tablets, Merck Sharp & Dohme Corp., Labeling Revision | Hyzaar (losartan potassium and hydrochlorothiazide) Tablets, Merck Sharp & Dohme Corp., Labeling Revision ^ FDA's latest approval appears at the bottom of this list. ^                                                                       A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U-Z Health Topics | For Industry | DMF Index | Pharma Job Search | Pharma Company 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