|
|
|
 |
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
|