APPLICATION
ANDA040792
TYPE
ANDA
ORIGINAL APPROVAL
2009-08-06
LATEST ACTION
2018-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
CARISOPRODOLPrescription
CARISOPRODOL 350MG · TABLET · ORAL
CARISOPRODOLPrescription
CARISOPRODOL 250MG · TABLET · ORAL
Approval history
2018-11-13Labeling · Supplement 14 · standardAP
2018-10-26Manufacturing (CMC) · Supplement 12AP
2016-11-08Manufacturing (CMC) · Supplement 6 · standardAP
2013-05-02Labeling · Supplement 4AP
2013-04-30Labeling · Supplement 9 · standardAP
2010-03-10Manufacturing (CMC) · Supplement 1AP
2010-03-03Labeling · Supplement 2AP
2009-08-06OriginalAP
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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