Details for New Drug Application (NDA): 022462

NDA 022462 describes GABLOFEN, which is a drug marketed by Piramal Critical and is included in one NDA. It is available from one supplier. Additional details are available on the GABLOFEN profile page.

The generic ingredient in GABLOFEN 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 022462

Tradename:	GABLOFEN
Applicant:	Piramal Critical
Ingredient:	baclofen
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 022462

Mechanism of Action

GABA A Agonists GABA B Agonists

Medical Subject Heading (MeSH) Categories for 022462

GABA-B Receptor Agonists

Muscle Relaxants, Central

Suppliers and Packaging for NDA: 022462

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
GABLOFEN	baclofen	INJECTABLE;INTRATHECAL	022462	NDA	Piramal Critical Care Inc	66794-151	66794-151-01	1 mL in 1 SYRINGE, GLASS (66794-151-01)
GABLOFEN	baclofen	INJECTABLE;INTRATHECAL	022462	NDA	Piramal Critical Care Inc	66794-155	66794-155-01	20 mL in 1 SYRINGE, GLASS (66794-155-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRATHECAL			Strength	0.05MG/ML
Approval Date:	Nov 19, 2010	TE:	AP	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRATHECAL			Strength	0.5MG/ML
Approval Date:	Nov 19, 2010	TE:	AP	RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRATHECAL			Strength	2MG/ML
Approval Date:	Nov 19, 2010	TE:	AP	RLD:	Yes

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