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FDA ANDA · ANDA040124

CARISOPRODOL

Sponsor: HIKMA INTL PHARMS

APPLICATION
ANDA040124
TYPE
ANDA
ORIGINAL APPROVAL
1996-01-24
LATEST ACTION
2015-06-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CARISOPRODOLDiscontinued
CARISOPRODOL 350MG · TABLET · ORAL

Approval history

2015-06-09Labeling · Supplement 20 · standardAP
2011-05-27Labeling · Supplement 18AP
2010-08-02Labeling · Supplement 16AP
2007-12-31Labeling · Supplement 14LetterAP
2002-06-12Manufacturing (CMC) · Supplement 11AP
2002-06-12Manufacturing (CMC) · Supplement 10AP
2001-10-15Manufacturing (CMC) · Supplement 9AP
2000-12-04Manufacturing (CMC) · Supplement 7AP
2000-12-04Manufacturing (CMC) · Supplement 5AP
2000-12-04Labeling · Supplement 8AP
2000-12-04Manufacturing (CMC) · Supplement 6AP
2000-12-04Manufacturing (CMC) · Supplement 4AP
1998-10-01Manufacturing (CMC) · Supplement 3AP
1998-07-24Manufacturing (CMC) · Supplement 2AP
1998-07-24Manufacturing (CMC) · Supplement 1AP
1996-01-24OriginalAP
VIEW ON DRUGS@FDA ↗

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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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