Last Updated: June 25, 2026

Details for New Drug Application (NDA): 077971

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NDA 077971 describes BACLOFEN, which is a drug marketed by Amneal, Heritage, Maia Pharms Inc, Pharmobedient, Rubicon Research, Ani Pharms, Andas 5 Holding, Aurobindo Pharma Ltd, Hibrow Hlthcare, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Oxford Pharms, Ph Health, Regcon Holdings, Rising, Somerset Theraps Llc, Sun Pharm Inds Inc, Teva, Unichem, Usl Pharma, Watson Labs, Yiling, and Zydus Lifesciences, and is included in forty-two NDAs. It is available from fifty-five suppliers. Additional details are available on the BACLOFEN profile page.

The generic ingredient in BACLOFEN is baclofen. There are twenty-one drug master file entries for this compound. Sixty-three suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for 077971

Tradename:	BACLOFEN
Applicant:	Impax
Ingredient:	baclofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 077971

GABA-B Receptor Agonists
Muscle Relaxants, Central

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 26, 2007	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Oct 26, 2007	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jul 7, 2021	TE:		RLD:	No

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