APPLICATION
ANDA073044
TYPE
ANDA
ORIGINAL APPROVAL
1992-02-27
LATEST ACTION
1997-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BACLOFENDiscontinued
BACLOFEN 20MG · TABLET · ORAL
Approval history
1997-06-18Manufacturing (CMC) · Supplement 9AP
1996-05-31Manufacturing (CMC) · Supplement 8AP
1996-03-11Manufacturing (CMC) · Supplement 7AP
1995-02-16Manufacturing (CMC) · Supplement 5AP
1994-09-06Manufacturing (CMC) · Supplement 4AP
1994-06-17Manufacturing (CMC) · Supplement 3AP
1994-05-16Manufacturing (CMC) · Supplement 2AP
1992-11-17Manufacturing (CMC) · Supplement 1AP
1992-02-27OriginalAP
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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