Last Updated: June 9, 2026

Details for New Drug Application (NDA): 077088

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NDA 077088 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-four suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for 077088

Tradename:	BACLOFEN
Applicant:	Oxford Pharms
Ingredient:	baclofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 077088

GABA-B Receptor Agonists
Muscle Relaxants, Central

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Oct 31, 2007	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Oct 31, 2007	TE:	AB	RLD:	No

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