APPLICATION
ANDA089346
TYPE
ANDA
ORIGINAL APPROVAL
1991-10-17
LATEST ACTION
2014-01-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CARISOPRODOLDiscontinued
CARISOPRODOL 350MG · TABLET · ORAL
Approval history
2014-01-30Labeling · Supplement 36 · standardAP
2013-07-26Labeling · Supplement 35 · standardAP
2010-03-09Labeling · Supplement 34AP
2009-03-20Labeling · Supplement 33AP
2007-01-25Labeling · Supplement 30AP
2002-09-27Labeling · Supplement 18AP
2002-09-27Manufacturing (CMC) · Supplement 16AP
2002-09-27Manufacturing (CMC) · Supplement 17AP
2001-11-06Manufacturing (CMC) · Supplement 13AP
2001-11-06Labeling · Supplement 14AP
2001-11-06Manufacturing (CMC) · Supplement 12AP
2001-06-08Manufacturing (CMC) · Supplement 11AP
2000-05-16Manufacturing (CMC) · Supplement 10AP
2000-05-16Manufacturing (CMC) · Supplement 9AP
1999-07-06Manufacturing (CMC) · Supplement 8AP
1998-01-15Manufacturing (CMC) · Supplement 7AP
1997-12-05Manufacturing (CMC) · Supplement 6AP
1997-12-05Manufacturing (CMC) · Supplement 4AP
1997-12-05Manufacturing (CMC) · Supplement 5AP
1997-02-24Manufacturing (CMC) · Supplement 3AP
1995-06-22Manufacturing (CMC) · Supplement 2AP
1994-01-12Manufacturing (CMC) · Supplement 1AP
1991-10-17OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.