APPLICATION
ANDA081025
TYPE
ANDA
ORIGINAL APPROVAL
1989-04-13
LATEST ACTION
2024-11-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARISOPRODOLPrescription
CARISOPRODOL 350MG · TABLET · ORAL
Approval history
2024-11-14Labeling · Supplement 20 · standardAP
2002-04-19Manufacturing (CMC) · Supplement 15AP
2002-03-25Manufacturing (CMC) · Supplement 13AP
2002-03-25Manufacturing (CMC) · Supplement 16AP
2002-03-25Labeling · Supplement 14AP
2002-03-25Manufacturing (CMC) · Supplement 12AP
2001-12-18Manufacturing (CMC) · Supplement 11AP
1999-05-05Manufacturing (CMC) · Supplement 10AP
1999-03-04Manufacturing (CMC) · Supplement 9AP
1998-12-30Manufacturing (CMC) · Supplement 8AP
1998-04-30Labeling · Supplement 7AP
1998-04-30Manufacturing (CMC) · Supplement 5AP
1998-04-30Manufacturing (CMC) · Supplement 3AP
1998-04-30Manufacturing (CMC) · Supplement 6AP
1998-04-30Manufacturing (CMC) · Supplement 4AP
1991-05-01Manufacturing (CMC) · Supplement 1AP
1989-04-13OriginalAP
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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