APPLICATION
ANDA077121
TYPE
ANDA
ORIGINAL APPROVAL
2005-07-29
LATEST ACTION
2020-05-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued
Products
BACLOFENPrescription
BACLOFEN 20MG · TABLET · ORAL
BACLOFENDiscontinued
BACLOFEN 20MG · TABLET · ORAL
Approval history
2020-05-04Labeling · Supplement 2 · standardAP
2005-07-29OriginalAP
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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