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Details for New Drug Application (NDA): 077492

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NDA 077492 describes VALSARTAN, which is a drug marketed by Amneal Pharms, Hetero Labs Ltd V, Prinston Inc, Aurobindo Pharma Ltd, Torrent Pharms Ltd, Ivax Pharms, Jubilant Generics, Watson Labs Inc, Mylan Labs Ltd, Alembic Pharms Ltd, Lupin Ltd, Ohm Labs Inc, Macleods Pharms Ltd, Mylan Pharms Inc, Apotex Inc, and Alembic Ltd, and is included in twenty-one NDAs. It is available from twenty-eight suppliers. Additional details are available on the VALSARTAN profile page.

The generic ingredient in VALSARTAN is hydrochlorothiazide; valsartan. There are thirty-one drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the hydrochlorothiazide; valsartan profile page.

Summary for NDA: 077492

Ohm Labs Inc
Therapeutic Class:Cardiovascular Agents

Pharmacology for NDA: 077492

Suppliers and Packaging for NDA: 077492

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TABLET;ORAL 077492 ANDA Aphena Pharma Solutions - Tennessee, LLC 43353-203 43353-203-79 2160 TABLET, FILM COATED in 1 BOTTLE (43353-203-79)
TABLET;ORAL 077492 ANDA Northwind Pharmaceuticals, LLC 51655-652 51655-652-52 30 TABLET, FILM COATED in 1 BOTTLE, DISPENSING (51655-652-52)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Jun 26, 2014TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength80MG
Approval Date:Jun 26, 2014TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength160MG
Approval Date:Jun 26, 2014TE:ABRLD:No

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