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FDA ANDA · ANDA089006

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: MALLINCKRODT

APPLICATION
ANDA089006
TYPE
ANDA
ORIGINAL APPROVAL
1985-08-09
LATEST ACTION
2002-05-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2002-05-20Manufacturing (CMC) · Supplement 32AP
2000-07-20Manufacturing (CMC) · Supplement 31AP
1997-06-05Manufacturing (CMC) · Supplement 28AP
1996-05-24Manufacturing (CMC) · Supplement 30AP
1995-03-15Labeling · Supplement 29AP
1994-09-29Manufacturing (CMC) · Supplement 27AP
1993-12-29Manufacturing (CMC) · Supplement 26AP
1993-03-05Bioequivalence · Supplement 25AP
1991-12-02Manufacturing (CMC) · Supplement 24AP
1991-05-08Manufacturing (CMC) · Supplement 22AP
1988-11-22Manufacturing (CMC) · Supplement 19AP
1988-11-22Manufacturing (CMC) · Supplement 3AP
1988-11-22Manufacturing (CMC) · Supplement 1AP
1988-11-22Manufacturing (CMC) · Supplement 15AP
1988-11-22Manufacturing (CMC) · Supplement 21AP
1988-11-22Manufacturing (CMC) · Supplement 18AP
1988-11-22Manufacturing (CMC) · Supplement 2AP
1988-11-22Manufacturing (CMC) · Supplement 14AP
1988-11-22Manufacturing (CMC) · Supplement 20AP
1988-11-22Manufacturing (CMC) · Supplement 12AP
1986-10-17Manufacturing (CMC) · Supplement 8AP
1986-10-17Manufacturing (CMC) · Supplement 6AP
1986-10-17Manufacturing (CMC) · Supplement 10AP
1986-10-17Manufacturing (CMC) · Supplement 9AP
1985-08-09OriginalAP
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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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