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 Drug Recalls 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… Diovan Tablets, Novartis NDA 020818 3/06/98 8/13/03 Diovan (valsartan) Capsules, Novartis NDA 20-665/S-004 11/27/98 Diovan (valsartan) Capsules & Tablets, Novartis NDA 21-283 7/18/01 5/5/03 8/12/03 Diovan (valsartan) Capsules & Tablets, Novartis NDA 20-665/S-016 & 21-283/S-001 8/14/02 8/21/02 8/14/02 2/3/03 Diovan (valsartan) Tablets, Novartis NDA 21-283/S-002 4/5/02 4/16/02 7/25/02 7/25/02 Diovan HCT (valsartan/hydrochlorothiazide) Tablets, 80/12.5 mg and 160/25 mg Novartis Corp. NDA 20-818/S16 1/15/03 1/23/03 7/8/03 Diovan HCT (valsartan/hydrochlorothiazide) Tablets, 80/12.5 mg and 160/12.5 mg. Novartis Corp. NDA 20-818/S12 Diovan (Valsartan) Tablet, Novartis NDA 21-283 7/18/01 Diovan Indications: Indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents. | Diovan (valsartan) Tablets, Novartis Pharma, Labeling Revision | Diovan HCT (valsartan/ hydrochlorothiazide) Tablets, Novartis Pharma, Labeling Revision | Diovan HCT (valsartan/ hydrochlorothiazide) Tablets, Novartis Pharma, Labeling Revision | Diovan (valsartan) Tablets, Novartis Pharma, New or Modified Indication | Diovan HCT (valsartan hydrochlorothiazide) Tablets, Novartis Pharma, New Dosage Regimen | Diovan (valsartan) Tablets, Novartis Pharma, Labeling Revision | Exforge (amlodipine and valsartan) Tablets, Novartis Pharma, Tentative Approval | Exforge (amlodipine and valsartan) Tablets, Novartis Pharma, Approval | Diovan (valsartan) Tablets, Novartis Pharma, Labeling Revision | Diovan HCT (valsartan/hydrochlorothiazide) Tablets, Novartis Pharma, Labeling Revision | Valsartan Tablet, Ranbaxy Labs, Tentative Approval | Diovan (valsartan) Tablets. Novartis Pharma, Patient Population Altered | Valsartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Valsartan Tablets, IVAX Pharmaceuticals, Inc., Tentative Approval | Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., New or Modified Indication ^ 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 | News Feed for each API | DMF Index | Pharma Job Search | Pharma Company News © 2008 Betterchem.com