APPLICATION
ANDA087499
TYPE
ANDA
ORIGINAL APPROVAL
1982-04-20
LATEST ACTION
2020-04-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARISOPRODOLPrescription
CARISOPRODOL 350MG · TABLET · ORAL
Approval history
2020-04-27Labeling · Supplement 55 · standardAP
2020-04-27Labeling · Supplement 58 · standardAP
2013-07-26Labeling · Supplement 54 · standardAP
2010-04-27Labeling · Supplement 47AP
2010-01-25Labeling · Supplement 43AP
2009-01-29Labeling · Supplement 37AP
2001-04-25Manufacturing (CMC) · Supplement 23AP
2001-03-22Manufacturing (CMC) · Supplement 22AP
1999-09-14Manufacturing (CMC) · Supplement 21AP
1998-12-21Manufacturing (CMC) · Supplement 18AP
1998-12-21Manufacturing (CMC) · Supplement 19AP
1998-12-21Manufacturing (CMC) · Supplement 17AP
1997-06-20Manufacturing (CMC) · Supplement 16AP
1991-12-19Manufacturing (CMC) · Supplement 9AP
1991-12-19Manufacturing (CMC) · Supplement 10AP
1991-12-19Manufacturing (CMC) · Supplement 8AP
1991-12-19Manufacturing (CMC) · Supplement 11AP
1991-01-28Manufacturing (CMC) · Supplement 14AP
1990-06-29Manufacturing (CMC) · Supplement 12AP
1989-12-20Bioequivalence · Supplement 15AP
1988-10-27Labeling · Supplement 7AP
1988-04-01Manufacturing (CMC) · Supplement 6AP
1986-01-07Manufacturing (CMC) · Supplement 5AP
1985-07-05Manufacturing (CMC) · Supplement 3AP
1985-07-05Manufacturing (CMC) · Supplement 4AP
1984-03-29Manufacturing (CMC) · Supplement 2AP
1983-04-21Manufacturing (CMC) · Supplement 1AP
1982-04-20OriginalAP
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.