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FDA ANDA · ANDA089160

ANEXSIA

Sponsor: MALLINCKRODT

APPLICATION
ANDA089160
TYPE
ANDA
ORIGINAL APPROVAL
1987-04-23
LATEST ACTION
2002-11-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

ANEXSIADiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL

Approval history

2002-11-13Labeling · Supplement 37AP
2002-11-05Manufacturing (CMC) · Supplement 36AP
2002-09-19Manufacturing (CMC) · Supplement 33AP
2002-09-19Labeling · Supplement 34AP
2002-07-15Manufacturing (CMC) · Supplement 35AP
2002-04-11Manufacturing (CMC) · Supplement 32AP
2000-03-15Manufacturing (CMC) · Supplement 29AP
2000-03-15Manufacturing (CMC) · Supplement 27AP
2000-03-15Manufacturing (CMC) · Supplement 25AP
2000-03-15Manufacturing (CMC) · Supplement 31AP
2000-03-15Manufacturing (CMC) · Supplement 23AP
2000-03-15Manufacturing (CMC) · Supplement 21AP
2000-03-15Manufacturing (CMC) · Supplement 28AP
2000-03-15Manufacturing (CMC) · Supplement 26AP
2000-03-15Labeling · Supplement 24AP
2000-03-15Manufacturing (CMC) · Supplement 30AP
2000-03-15Manufacturing (CMC) · Supplement 22AP
1998-07-30Manufacturing (CMC) · Supplement 17AP
1997-07-11Labeling · Supplement 12AP
1995-05-12Manufacturing (CMC) · Supplement 8AP
1995-05-12Manufacturing (CMC) · Supplement 9AP
1995-05-12Manufacturing (CMC) · Supplement 10AP
1995-04-19Labeling · Supplement 7AP
1991-06-21Labeling · Supplement 6AP
1988-09-30Manufacturing (CMC) · Supplement 3AP
1987-04-23OriginalAP
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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