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FDA ANDA · ANDA087406

OXYCODONE AND ACETAMINOPHEN

Sponsor: BARR

APPLICATION
ANDA087406
TYPE
ANDA
ORIGINAL APPROVAL
1981-11-02
LATEST ACTION
1999-12-21
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

OXYCODONE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 325MG, OXYCODONE HYDROCHLORIDE 5MG · TABLET · ORAL

Approval history

1999-12-21Manufacturing (CMC) · Supplement 37AP
1999-05-20Manufacturing (CMC) · Supplement 36AP
1999-04-07Manufacturing (CMC) · Supplement 35AP
1998-12-01Manufacturing (CMC) · Supplement 34AP
1997-06-26Manufacturing (CMC) · Supplement 31AP
1997-06-26Manufacturing (CMC) · Supplement 32AP
1997-06-26Manufacturing (CMC) · Supplement 30AP
1997-06-26Manufacturing (CMC) · Supplement 29AP
1997-06-26Labeling · Supplement 33AP
1994-12-23Manufacturing (CMC) · Supplement 28AP
1994-01-24Labeling · Supplement 27AP
1992-04-29Manufacturing (CMC) · Supplement 23AP
1992-04-29Manufacturing (CMC) · Supplement 22AP
1992-04-03Manufacturing (CMC) · Supplement 26AP
1992-04-03Manufacturing (CMC) · Supplement 24AP
1991-04-22Manufacturing (CMC) · Supplement 21AP
1989-05-17Labeling · Supplement 20AP
1988-05-13Manufacturing (CMC) · Supplement 19AP
1987-03-30Manufacturing (CMC) · Supplement 12AP
1987-03-20Manufacturing (CMC) · Supplement 8AP
1987-03-20Manufacturing (CMC) · Supplement 7AP
1984-12-31Manufacturing (CMC) · Supplement 4AP
1983-07-29Manufacturing (CMC) · Supplement 3AP
1981-11-02OriginalAP
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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