Details for New Drug Application (NDA): 078401

NDA 078401 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-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for 078401

Tradename:	BACLOFEN
Applicant:	Northstar Hlthcare
Ingredient:	baclofen
Patents:	0

Pharmacology for NDA: 078401

Mechanism of Action

GABA A Agonists GABA B Agonists

Medical Subject Heading (MeSH) Categories for 078401

GABA-B Receptor Agonists

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 078401

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
BACLOFEN	baclofen	TABLET;ORAL	078401	ANDA	Northstar RxLLC	16714-072	16714-072-04	100 TABLET in 1 BOTTLE (16714-072-04)
BACLOFEN	baclofen	TABLET;ORAL	078401	ANDA	Northstar RxLLC	16714-072	16714-072-05	500 TABLET in 1 BOTTLE (16714-072-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Sep 18, 2009	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 18, 2009	TE:	AB	RLD:	No

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