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Last Updated: December 13, 2024

Details for New Drug Application (NDA): 077121

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NDA 077121 describes BACLOFEN, which is a drug marketed by Amneal, Heritage, Maia Pharms Inc, Mylan Labs Ltd, Rubicon, Ani Pharms, Andas 5 Holding, Appco, Aurobindo Pharma Ltd, Beximco Pharms Usa, Endo Operations, Eywa, Graviti Pharms, Impax, Ivax Sub Teva Pharms, Lannett Co Inc, Mankind Pharma, Micro Labs, Northstar Hlthcare, Norvium Bioscience, Oxford Pharms, Rising, Sun Pharm Inds Inc, Teva, Unichem, Upsher Smith Labs, Usl Pharma, Watson Labs, and Zydus Lifesciences, and is included in forty-one 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 077121

Tradename:	BACLOFEN
Applicant:	Norvium Bioscience
Ingredient:	baclofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 077121

GABA-B Receptor Agonists
Muscle Relaxants, Central

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jul 29, 2005	TE:		RLD:	No

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