APPLICATION
ANDA090334
TYPE
ANDA
ORIGINAL APPROVAL
2010-02-18
LATEST ACTION
2023-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued, Prescription
Products
BACLOFENDiscontinued
BACLOFEN 20MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 5MG · TABLET · ORAL
BACLOFENDiscontinued
BACLOFEN 10MG · TABLET · ORAL
Approval history
2023-05-23Labeling · Supplement 3 · standardAP
2010-02-18OriginalAP
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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