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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 078020


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NDA 078020 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 078020
Pharmacology for NDA: 078020
Mechanism of ActionAngiotensin 2 Receptor Antagonists
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 078020
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078020 ANDA Mylan Pharmaceuticals Inc. 0378-6321 0378-6321-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6321-77)
VALSARTAN AND HYDROCHLOROTHIAZIDE hydrochlorothiazide; valsartan TABLET;ORAL 078020 ANDA Mylan Pharmaceuticals Inc. 0378-6322 0378-6322-77 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-6322-77)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;80MG
Approval Date:Sep 21, 2012TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;160MG
Approval Date:Sep 21, 2012TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;160MG
Approval Date:Sep 21, 2012TE:ABRLD:No

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