APPLICATION
ANDA077241
TYPE
ANDA
ORIGINAL APPROVAL
2005-12-20
LATEST ACTION
2021-09-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BACLOFENPrescription
BACLOFEN 10MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 5MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 20MG · TABLET · ORAL
Approval history
2021-09-22Manufacturing (CMC) · Supplement 21 · unknownAP
2020-10-29Labeling · Supplement 20 · standardAP
2015-04-16Labeling · Supplement 1AP
2015-04-16Labeling · Supplement 11 · standardAP
2008-08-13Labeling · Supplement 5AP
2005-12-20OriginalAP
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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