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Last Updated: November 24, 2024

Details for New Drug Application (NDA): 201662


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NDA 201662 describes VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Watson Labs Teva, and Zydus Lifesciences, and is included in ten NDAs. It is available from eighteen suppliers. Additional details are available on the VALSARTAN AND HYDROCHLOROTHIAZIDE profile page.

The generic ingredient in VALSARTAN AND HYDROCHLOROTHIAZIDE is hydrochlorothiazide; valsartan. There are thirty-two drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 201662
Pharmacology for NDA: 201662
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 201662
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 201662 ANDA Alembic Pharmaceuticals Limited 46708-453 46708-453-10 100 TABLET, FILM COATED in 1 CARTON (46708-453-10)
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 201662 ANDA Alembic Pharmaceuticals Limited 46708-453 46708-453-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-453-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Mar 21, 2013TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Mar 21, 2013TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;320MG
Approval Date:Mar 21, 2013TE:ABRLD:No

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