APPLICATION
ANDA072235
TYPE
ANDA
ORIGINAL APPROVAL
1988-07-21
LATEST ACTION
2020-05-06
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
BACLOFENPrescription
BACLOFEN 20MG · TABLET · ORAL
Approval history
2020-05-06Labeling · Supplement 38 · standardAP
2010-12-01Manufacturing (CMC) · Supplement 30AP
2009-04-03Labeling · Supplement 26AP
2002-07-29Manufacturing (CMC) · Supplement 12AP
2001-06-04Manufacturing (CMC) · Supplement 10AP
2000-01-28Manufacturing (CMC) · Supplement 7AP
1999-04-19Manufacturing (CMC) · Supplement 6AP
1998-10-26Manufacturing (CMC) · Supplement 5AP
1996-09-05Manufacturing (CMC) · Supplement 1AP
1995-07-12Manufacturing (CMC) · Supplement 2AP
1995-04-06Manufacturing (CMC) · Supplement 3AP
1988-07-21OriginalAP
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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