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FDA ANDA · ANDA089271

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: MIKART

APPLICATION
ANDA089271
TYPE
ANDA
ORIGINAL APPROVAL
1986-07-16
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2002-08-13Manufacturing (CMC) · Supplement 39AP
2000-08-31Manufacturing (CMC) · Supplement 32AP
2000-08-31Manufacturing (CMC) · Supplement 29AP
2000-08-31Manufacturing (CMC) · Supplement 33AP
2000-08-31Manufacturing (CMC) · Supplement 31AP
1998-09-09Manufacturing (CMC) · Supplement 38AP
1998-07-31Manufacturing (CMC) · Supplement 37AP
1998-01-14Manufacturing (CMC) · Supplement 36AP
1997-02-07Labeling · Supplement 30AP
1996-09-18Manufacturing (CMC) · Supplement 34AP
1996-09-18Manufacturing (CMC) · Supplement 35AP
1995-07-19Manufacturing (CMC) · Supplement 28AP
1995-02-08Manufacturing (CMC) · Supplement 27AP
1993-07-20Manufacturing (CMC) · Supplement 10AP
1993-07-20Manufacturing (CMC) · Supplement 9AP
1992-05-13Manufacturing (CMC) · Supplement 26AP
1992-01-06Labeling · Supplement 21AP
1992-01-06Manufacturing (CMC) · Supplement 24AP
1992-01-06Manufacturing (CMC) · Supplement 22AP
1992-01-06Manufacturing (CMC) · Supplement 20AP
1992-01-06Manufacturing (CMC) · Supplement 25AP
1992-01-06Labeling · Supplement 23AP
1991-02-21Manufacturing (CMC) · Supplement 19AP
1990-09-14Manufacturing (CMC) · Supplement 15AP
1990-09-14Manufacturing (CMC) · Supplement 14AP
1989-11-21Labeling · Supplement 17AP
1989-04-11Bioequivalence · Supplement 16AP
1989-03-02Manufacturing (CMC) · Supplement 13AP
1989-03-02Manufacturing (CMC) · Supplement 11AP
1989-03-02Manufacturing (CMC) · Supplement 12AP
1988-06-17Manufacturing (CMC) · Supplement 4AP
1988-05-12Manufacturing (CMC) · Supplement 1AP
1988-04-15Manufacturing (CMC) · Supplement 2AP
1986-07-16OriginalAP
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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