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FDA ANDA · ANDA087757

CO-GESIC

Sponsor: UCB INC

APPLICATION
ANDA087757
TYPE
ANDA
ORIGINAL APPROVAL
1982-05-03
LATEST ACTION
2008-01-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

CO-GESICDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL

Approval history

2008-01-26Manufacturing (CMC) · Supplement 30AP
1999-11-29Manufacturing (CMC) · Supplement 27AP
1998-12-09Manufacturing (CMC) · Supplement 26AP
1996-04-30Manufacturing (CMC) · Supplement 25AP
1995-12-06Manufacturing (CMC) · Supplement 23AP
1995-12-06Labeling · Supplement 21AP
1995-12-06Manufacturing (CMC) · Supplement 22AP
1995-12-06Manufacturing (CMC) · Supplement 20AP
1994-12-20Manufacturing (CMC) · Supplement 24AP
1992-10-29Manufacturing (CMC) · Supplement 11AP
1991-08-30Manufacturing (CMC) · Supplement 19AP
1990-03-29Labeling · Supplement 16AP
1989-05-15Labeling · Supplement 17AP
1989-04-20Manufacturing (CMC) · Supplement 14AP
1989-02-07Labeling · Supplement 15AP
1986-04-29Manufacturing (CMC) · Supplement 9AP
1985-05-13Manufacturing (CMC) · Supplement 6AP
1984-01-24Manufacturing (CMC) · Supplement 4AP
1984-01-24Manufacturing (CMC) · Supplement 2AP
1982-05-03OriginalAP
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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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