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Last Updated: July 16, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078946

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NDA 078946 describes VALSARTAN AND HYDROCHLOROTHIAZIDE, which is a drug marketed by Alembic Pharms Ltd, Apotex Inc, Aurobindo Pharma Ltd, Lupin Ltd, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Watson Labs Teva, and Zydus Pharms, and is included in nine NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.
Summary for 078946
Pharmacology for NDA: 078946
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 078946
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078946 ANDA Lupin Pharmaceuticals, Inc. 68180-101 68180-101-02 500 TABLET, FILM COATED in 1 BOTTLE (68180-101-02)
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078946 ANDA Lupin Pharmaceuticals, Inc. 68180-101 68180-101-09 90 TABLET, FILM COATED in 1 BOTTLE (68180-101-09)

Profile for product number 001

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

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;320MG
Approval Date:Mar 21, 2013TE:ABRLD:No

Profile for product number 003

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

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