APPLICATION
ANDA209102
TYPE
ANDA
ORIGINAL APPROVAL
2017-11-28
LATEST ACTION
2024-02-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BACLOFENPrescription
BACLOFEN 5MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 15MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 10MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 20MG · TABLET · ORAL
Approval history
2024-02-05Manufacturing (CMC) · Supplement 15 · unknownAP
2023-09-12Labeling · Supplement 8 · 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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