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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 213605

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NDA 213605 describes SACUBITRIL AND VALSARTAN, which is a drug marketed by Alembic, Alkem Labs Ltd, Biocon Pharma, Crystal, Laurus, Macleods Pharms Ltd, MSN, Torrent, and Zydus Pharms, and is included in nine NDAs. It is available from four suppliers. Additional details are available on the SACUBITRIL AND VALSARTAN profile page.

The generic ingredient in SACUBITRIL AND VALSARTAN is sacubitril; valsartan. There are eleven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the sacubitril; valsartan profile page.

Summary for 213605

Tradename:	SACUBITRIL AND VALSARTAN
Applicant:	Crystal
Ingredient:	sacubitril; valsartan
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	24MG;26MG
Approval Date:	May 28, 2024	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	49MG;51MG
Approval Date:	May 28, 2024	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	97MG;103MG
Approval Date:	May 28, 2024	TE:	AB	RLD:	No

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