Details for New Drug Application (NDA): 020075

NDA 020075 describes LIORESAL, which is a drug marketed by Amneal and Novartis and is included in two NDAs. It is available from two suppliers. 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-five suppliers are listed for this compound. Additional details are available on the baclofen profile page.

Summary for 020075

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

Pharmacology for NDA: 020075

Mechanism of Action

GABA A Agonists GABA B Agonists

Medical Subject Heading (MeSH) Categories for 020075

GABA-B Receptor Agonists

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 020075

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075	NDA	Amneal Pharmaceuticals LLC	70121-2496	70121-2496-5	5 AMPULE in 1 BOX (70121-2496-5) / 1 mL in 1 AMPULE
LIORESAL	baclofen	INJECTABLE;INTRATHECAL	020075	NDA	Amneal Pharmaceuticals LLC	70121-2501	70121-2501-1	1 AMPULE in 1 BOX (70121-2501-1) / 1 KIT in 1 AMPULE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRATHECAL			Strength	0.5MG/ML
Approval Date:	Jun 17, 1992	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRATHECAL			Strength	2MG/ML
Approval Date:	Jun 17, 1992	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRATHECAL			Strength	0.05MG/ML
Approval Date:	Nov 7, 1996	TE:	AP	RLD:	Yes

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