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FDA ANDA · ANDA081083

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: WATSON LABS

APPLICATION
ANDA081083
TYPE
ANDA
ORIGINAL APPROVAL
1991-08-30
LATEST ACTION
2008-01-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 750MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL

Approval history

2008-01-09Manufacturing (CMC) · Supplement 34AP
2002-08-08Manufacturing (CMC) · Supplement 19AP
2002-08-08Manufacturing (CMC) · Supplement 21AP
2002-05-21Manufacturing (CMC) · Supplement 18AP
2001-09-05Manufacturing (CMC) · Supplement 17AP
2000-03-29Labeling · Supplement 15AP
1999-10-27Manufacturing (CMC) · Supplement 16AP
1998-10-29Manufacturing (CMC) · Supplement 14AP
1998-10-07Manufacturing (CMC) · Supplement 13AP
1997-12-04Manufacturing (CMC) · Supplement 8AP
1997-12-04Manufacturing (CMC) · Supplement 10AP
1997-12-04Manufacturing (CMC) · Supplement 9AP
1997-08-08Labeling · Supplement 12AP
1996-05-10Labeling · Supplement 7AP
1995-12-22Labeling · Supplement 5AP
1995-08-21Manufacturing (CMC) · Supplement 4AP
1994-10-20Labeling · Supplement 3AP
1993-10-22Manufacturing (CMC) · Supplement 2AP
1992-09-08Labeling · Supplement 1AP
1991-08-30OriginalAP
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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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