APPLICATION
ANDA074584
TYPE
ANDA
ORIGINAL APPROVAL
1996-08-19
LATEST ACTION
2011-06-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BACLOFENPrescription
BACLOFEN 20MG · TABLET · ORAL
BACLOFENPrescription
BACLOFEN 10MG · TABLET · ORAL
Approval history
2011-06-17Labeling · Supplement 18AP
2005-09-20Labeling · Supplement 4AP
1996-08-19OriginalAP
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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