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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 021961

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NDA 021961 describes SIMVASTATIN, which is a drug marketed by Synthon Pharms, Accord Hlthcare, Aurobindo Pharma, Biocon Pharma, Chartwell Rx, Hetero Labs Ltd Iii, Invagen Pharms, Ivax Sub Teva Pharms, Lupin, Micro Labs, Oxford Pharms, Pharmobedient, Rising, Sun Pharm Inds Ltd, Watson Labs Teva, Yiling, and Zydus Pharms Usa, and is included in seventeen NDAs. It is available from twenty-nine suppliers. Additional details are available on the SIMVASTATIN profile page.

The generic ingredient in SIMVASTATIN is simvastatin. There are forty drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the simvastatin profile page.

Summary for 021961

Tradename:	SIMVASTATIN
Applicant:	Synthon Pharms
Ingredient:	simvastatin
Patents:	0

Medical Subject Heading (MeSH) Categories for 021961

Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	10MG
Approval Date:	Oct 9, 2007	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	20MG
Approval Date:	Oct 9, 2007	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET, ORALLY DISINTEGRATING;ORAL			Strength	40MG
Approval Date:	Oct 9, 2007	TE:		RLD:	Yes

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