← FDA DRUG APPROVALS

FDA NDA · NDA208193

BACLOFEN

Sponsor: METACEL PHARMS LLC

APPLICATION
NDA208193
TYPE
NDA
ORIGINAL APPROVAL
2019-09-18
LATEST ACTION
2023-10-12
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription, Discontinued

Products

OZOBAX DS · ReferencePrescription
BACLOFEN 10MG/5ML · SOLUTION · ORAL
OZOBAX · ReferenceDiscontinued
BACLOFEN 5MG/5ML · SOLUTION · ORAL

Approval history

2023-10-12Manufacturing (CMC) · Supplement 2 — Label ↗AP
2019-09-18Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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.

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