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Last Updated: March 26, 2026

Details for New Drug Application (NDA): 209461

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NDA 209461 describes EZETIMIBE AND SIMVASTATIN, which is a drug marketed by Alkem Labs Ltd, Amneal Pharms Co, Ani Pharms, Aurobindo Pharma Usa, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Sciegen Pharms, Torrent, and Watson Labs Inc, and is included in nine NDAs. It is available from nine suppliers. Additional details are available on the EZETIMIBE AND SIMVASTATIN profile page.

The generic ingredient in EZETIMIBE AND SIMVASTATIN is ezetimibe; simvastatin. There are twenty-four drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ezetimibe; simvastatin profile page.

Summary for 209461

Tradename:	EZETIMIBE AND SIMVASTATIN
Applicant:	Torrent
Ingredient:	ezetimibe; simvastatin
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;10MG
Approval Date:	Jan 27, 2025	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;20MG
Approval Date:	Jan 27, 2025	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG;40MG
Approval Date:	Jan 27, 2025	TE:		RLD:	No

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