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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 | Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Approval | Diovan (valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Valturna (aliskiren and valsartan) Tablets, Novartis Pharmaceuticals Corp., Approval | Amlodipine and Valsartan Tablets, Matrix Laboratories Ltd., Tentative Approval | Amlodipine and Valsartan Tablets, Par Pharmaceutical, Inc., Tentative Approval | Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Amlodipine and Valsartan Tablets, Synthon Pharmaceuticals, Inc., Tentative Approval | Diovan HCT (valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Valsartan and Hydrochlorothiazide Tablets, Mylan Pharmaceuticals Inc., Tentative Approval | Valturna (aliskiren hemifumarate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Valturna (aliskiren hemifumarate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Diovan (valsartan) Tablets, Novartis, Labeling Revision | Diovan HCT (hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals, Labeling Revision | Exforge HCT (amlodipine besylate, hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Valturna (aliskiren hemifumarate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Exforge (amlodipine and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Exforge HCT (amlodipine, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Exforge (amlodipine besylate and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Exforge HCT (amlodipine besylate, valsartan and hydrochlorothiazide) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Diovan (valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision | Diovan HCT (hydrochlorothiazide and valsartan) Tablets, Novartis Pharmaceuticals Corp., Labeling Revision
  
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