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FDA ANDA · ANDA214099

BACLOFEN

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA214099
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-13
LATEST ACTION
2025-11-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BACLOFENPrescription
BACLOFEN 10MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 20MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 5MG · TABLET · ORAL

Approval history

2025-11-21Manufacturing (CMC) · Supplement 3 · unknownAP
2021-07-13UNKNOWN · Original · standardAP
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.

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