Details for New Drug Application (NDA): 017851

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NDA 017851 describes LIORESAL, which is a drug marketed by Amneal and Novartis and is included in two NDAs. It is available from one supplier. Additional details are available on the LIORESAL profile page.

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

Summary for 017851

Tradename:	LIORESAL
Applicant:	Novartis
Ingredient:	baclofen
Patents:	0

Medical Subject Heading (MeSH) Categories for 017851

GABA-B Receptor Agonists
Muscle Relaxants, Central

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jan 20, 1982	TE:		RLD:	Yes

Expired US Patents for NDA 017851

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-001	Approved Prior to Jan 1, 1982	⤷ Start Trial	⤷ Start Trial
Novartis	LIORESAL	baclofen	TABLET;ORAL	017851-003	Jan 20, 1982	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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