APPLICATION
ANDA212378
TYPE
ANDA
ORIGINAL APPROVAL
2020-10-09
LATEST ACTION
2025-06-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BACLOFENPrescription
BACLOFEN 20MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 5MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 10MG · TABLET · ORAL
Approval history
2025-06-03Manufacturing (CMC) · Supplement 7 · unknownAP
2021-04-30Manufacturing (CMC) · Supplement 1 · unknownAP
2020-10-09UNKNOWN · Original · standardAP
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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