← FDA Drug Approvals (Drugs@FDA)

GABLOFEN

NDA · New Drug Application · Sponsor: PIRAMAL CRITICAL · Approved 2010-11-19

Drug application

FDA Application #

NDA022462

Application type

New Drug Application

Brand name

GABLOFEN

Generic name

Baclofen

Active ingredients

BACLOFEN

Dosage form

INJECTABLE

Route

INTRATHECAL

Marketing status

Prescription

Sponsor

PIRAMAL CRITICAL

First approval

2010-11-19

Source

Authoritative

Drugs@FDA application overview

Machine

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