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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 090334

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NDA 090334 describes BACLOFEN, which is a drug marketed by Amneal, Heritage, Maia Pharms Inc, Pharmobedient, Rubicon Research, Ani Pharms, Andas 5 Holding, Appco, 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, 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-eight 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-six suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for 090334

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

Medical Subject Heading (MeSH) Categories for 090334

GABA-B Receptor Agonists
Muscle Relaxants, Central

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Feb 18, 2010	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Feb 18, 2010	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	5MG
Approval Date:	Jan 31, 2025	TE:	AB	RLD:	No

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