APPLICATION
ANDA214445
TYPE
ANDA
ORIGINAL APPROVAL
2024-12-06
LATEST ACTION
2025-06-03
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription
Products
BACLOFENPrescription
BACLOFEN 5MG/5ML · SOLUTION · ORAL
BACLOFENPrescription
BACLOFEN 10MG/5ML · SOLUTION · ORAL
Approval history
2025-06-03Manufacturing (CMC) · Supplement 2 · unknownAP
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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