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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 091235

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NDA 091235 describes AMLODIPINE BESYLATE AND VALSARTAN, which is a drug marketed by Alembic, Aurobindo Pharma, Hetero Labs, Lupin, Macleods Pharms Ltd, Mylan, Novel Labs Inc, Strides Pharma Intl, Teva Pharms Usa, and Torrent, and is included in ten NDAs. It is available from nine suppliers. Additional details are available on the AMLODIPINE BESYLATE AND VALSARTAN profile page.

The generic ingredient in AMLODIPINE BESYLATE AND VALSARTAN is amlodipine besylate; valsartan. There are fifty drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the amlodipine besylate; valsartan profile page.

Summary for 091235

Tradename:	AMLODIPINE BESYLATE AND VALSARTAN
Applicant:	Teva Pharms Usa
Ingredient:	amlodipine besylate; valsartan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;160MG
Approval Date:	Mar 30, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE;160MG
Approval Date:	Mar 30, 2015	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE;320MG
Approval Date:	Mar 30, 2015	TE:		RLD:	No

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