MedPath
FDA Product

Diovan

Product approved by U.S. Food and Drug Administration (US)

Basic Information

Diovan

0078-0358

Regulatory Information

0078-0358

NDA021283

C73594

September 21, 2016

USA

These highlights do not include all the information needed to use DIOVAN safely and effectively. See full prescribing information for DIOVAN. DIOVAN (valsartan) tablets, for oral use Initial U.S. Approval: 1996

HUMAN PRESCRIPTION DRUG LABEL

26

Company Information

002147023

Active Ingredients

VALSARTAN

Quantity: 80 mg in 1 1

Code: 80M03YXJ7I

Class Code: ACTIB

SILICON DIOXIDE

Code: ETJ7Z6XBU4

Class Code: IACT

HYPROMELLOSES

Code: 3NXW29V3WO

Class Code: IACT

FERRIC OXIDE RED

Code: 1K09F3G675

Class Code: IACT

CELLULOSE, MICROCRYSTALLINE

Code: OP1R32D61U

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

POLYETHYLENE GLYCOL 8000

Code: Q662QK8M3B

Class Code: IACT

CROSPOVIDONE

Code: 68401960MK

Class Code: IACT

MAGNESIUM STEARATE

Code: 70097M6I30

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

Active Moieties

VALSARTAN

Code: 80M03YXJ7I

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