← FDA DRUG APPROVALS

FDA NDA · NDA022462

GABLOFEN

baclofen injection

Sponsor: PIRAMAL CRITICAL

APPLICATION
NDA022462
TYPE
NDA
ORIGINAL APPROVAL
2010-11-19
LATEST ACTION
2022-05-31
ROUTE
INTRATHECAL
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

GABLOFEN · ReferencePrescription
BACLOFEN 1MG/ML · INJECTABLE · INTRATHECAL
GABLOFEN · ReferencePrescription
BACLOFEN 0.5MG/ML · INJECTABLE · INTRATHECAL
GABLOFEN · ReferencePrescription
BACLOFEN 2MG/ML · INJECTABLE · INTRATHECAL
GABLOFEN · ReferencePrescription
BACLOFEN 0.05MG/ML · INJECTABLE · INTRATHECAL

Approval history

2022-05-31Labeling · Supplement 15 · standard — Letter ↗AP
2021-04-19Labeling · Supplement 13 · standard — Letter ↗AP
2019-12-19Labeling · Supplement 11 · standard — Letter ↗AP
2015-02-11Labeling · Supplement 8 · standard — Label ↗AP
2013-01-17Manufacturing (CMC) · Supplement 4 · standardAP
2012-06-22Manufacturing (CMC) · Supplement 2 · standardAP
2010-11-19Type 5 - New Formulation or New Manufacturer · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →