APPLICATION
ANDA073092
TYPE
ANDA
ORIGINAL APPROVAL
1994-01-28
LATEST ACTION
2020-05-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
BACLOFENDiscontinued
BACLOFEN 10MG · TABLET · ORAL
Approval history
2020-05-06Labeling · Supplement 16 · standardAP
2001-04-12Manufacturing (CMC) · Supplement 15AP
2000-03-21Manufacturing (CMC) · Supplement 13AP
1998-01-20Manufacturing (CMC) · Supplement 11AP
1997-07-08Manufacturing (CMC) · Supplement 9AP
1997-03-26Manufacturing (CMC) · Supplement 3AP
1997-02-28Manufacturing (CMC) · Supplement 7AP
1997-01-07Manufacturing (CMC) · Supplement 8AP
1996-12-31Manufacturing (CMC) · Supplement 5AP
1996-12-31Manufacturing (CMC) · Supplement 4AP
1996-01-17Manufacturing (CMC) · Supplement 2AP
1994-10-13Manufacturing (CMC) · Supplement 1AP
1994-01-28OriginalAP
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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