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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 201677

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NDA 201677 describes VALSARTAN, which is a drug marketed by Novitium Pharma, Rubicon, Acme Labs, Alembic, Alkem Labs Ltd, Amneal Pharms, Aurobindo Pharma Ltd, Dr Reddys, Hetero Labs Ltd V, Ivax Pharms, Jubilant Generics, Lupin Ltd, Macleods Pharms Ltd, Mylan, Ohm Labs Inc, Prinston Inc, Sciegen Pharms Inc, Somerset Theraps Llc, Torrent, Unichem, Watson Labs Inc, Zydus Lifesciences, Apotex Inc, Mylan Pharms Inc, and Watson Labs Teva, and is included in thirty-two NDAs. It is available from thirty-two suppliers. Additional details are available on the VALSARTAN profile page.

The generic ingredient in VALSARTAN 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 201677

Tradename:	VALSARTAN
Applicant:	Lupin Ltd
Ingredient:	valsartan
Patents:	0

Pharmacology for NDA: 201677

Mechanism of Action	Angiotensin 2 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for 201677

Angiotensin II Type 1 Receptor Blockers
Antihypertensive Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jan 5, 2015	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	80MG
Approval Date:	Jan 5, 2015	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	160MG
Approval Date:	Jan 5, 2015	TE:	AB	RLD:	No

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