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FDA ANDA · ANDA088956

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: MALLINCKRODT

APPLICATION
ANDA088956
TYPE
ANDA
ORIGINAL APPROVAL
1985-07-19
LATEST ACTION
2000-07-20
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

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

Approval history

2000-07-20Manufacturing (CMC) · Supplement 32AP
1997-06-05Manufacturing (CMC) · Supplement 29AP
1996-04-10Labeling · Supplement 30AP
1994-09-29Manufacturing (CMC) · Supplement 28AP
1993-12-21Manufacturing (CMC) · Supplement 27AP
1991-12-16Manufacturing (CMC) · Supplement 25AP
1991-09-03Labeling · Supplement 24AP
1991-07-11Manufacturing (CMC) · Supplement 22AP
1990-06-04Labeling · Supplement 23AP
1989-11-03Manufacturing (CMC) · Supplement 9AP
1989-11-03Manufacturing (CMC) · Supplement 11AP
1989-11-03Manufacturing (CMC) · Supplement 3AP
1989-11-03Manufacturing (CMC) · Supplement 8AP
1989-11-03Labeling · Supplement 10AP
1989-04-06Manufacturing (CMC) · Supplement 7AP
1989-04-06Manufacturing (CMC) · Supplement 6AP
1989-04-06Manufacturing (CMC) · Supplement 4AP
1985-07-19OriginalAP
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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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