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FDA ANDA · ANDA089883

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: WATSON LABS

APPLICATION
ANDA089883
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-01
LATEST ACTION
2008-03-20
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL

Approval history

2008-03-20Manufacturing (CMC) · Supplement 42AP
2008-01-09Manufacturing (CMC) · Supplement 39AP
2002-08-08Manufacturing (CMC) · Supplement 23AP
2002-08-08Manufacturing (CMC) · Supplement 25AP
2002-05-21Manufacturing (CMC) · Supplement 22AP
2001-09-05Manufacturing (CMC) · Supplement 21AP
2000-03-29Labeling · Supplement 19AP
2000-03-15Manufacturing (CMC) · Supplement 20AP
1998-10-29Manufacturing (CMC) · Supplement 18AP
1998-10-07Manufacturing (CMC) · Supplement 17AP
1997-12-04Manufacturing (CMC) · Supplement 13AP
1997-12-04Manufacturing (CMC) · Supplement 16AP
1997-12-04Manufacturing (CMC) · Supplement 14AP
1997-08-08Labeling · Supplement 15AP
1996-05-10Labeling · Supplement 12AP
1995-12-22Labeling · Supplement 11AP
1994-10-20Labeling · Supplement 10AP
1993-05-28Manufacturing (CMC) · Supplement 9AP
1993-05-28Manufacturing (CMC) · Supplement 7AP
1993-05-28Labeling · Supplement 8AP
1992-04-08Labeling · Supplement 6AP
1992-03-04Labeling · Supplement 5AP
1990-10-12Labeling · Supplement 4AP
1990-06-07Labeling · Supplement 3AP
1989-02-03Labeling · Supplement 1AP
1988-12-01OriginalAP
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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