APPLICATION
ANDA087722
TYPE
ANDA
ORIGINAL APPROVAL
1982-07-09
LATEST ACTION
2000-12-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LORTABDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
Approval history
2000-12-26Manufacturing (CMC) · Supplement 39AP
1999-06-29Manufacturing (CMC) · Supplement 38AP
1998-10-29Manufacturing (CMC) · Supplement 21AP
1998-10-29Labeling · Supplement 22AP
1998-10-29Manufacturing (CMC) · Supplement 20AP
1998-10-29Manufacturing (CMC) · Supplement 19AP
1996-04-25Manufacturing (CMC) · Supplement 37AP
1996-03-01Labeling · Supplement 36AP
1994-09-29Manufacturing (CMC) · Supplement 35AP
1994-01-21Manufacturing (CMC) · Supplement 34AP
1993-07-30Manufacturing (CMC) · Supplement 33AP
1993-02-26Manufacturing (CMC) · Supplement 31AP
1993-02-26Manufacturing (CMC) · Supplement 32AP
1992-03-06Manufacturing (CMC) · Supplement 30AP
1991-11-12Manufacturing (CMC) · Supplement 29AP
1990-06-06Manufacturing (CMC) · Supplement 27AP
1988-12-14Manufacturing (CMC) · Supplement 25AP
1988-12-14Manufacturing (CMC) · Supplement 23AP
1988-12-14Manufacturing (CMC) · Supplement 24AP
1986-07-24Manufacturing (CMC) · Supplement 16AP
1985-11-14Manufacturing (CMC) · Supplement 14AP
1985-03-13Manufacturing (CMC) · Supplement 8AP
1985-03-13Manufacturing (CMC) · Supplement 13AP
1985-03-13Manufacturing (CMC) · Supplement 11AP
1985-03-13Manufacturing (CMC) · Supplement 9AP
1985-03-13Manufacturing (CMC) · Supplement 10AP
1984-01-13Manufacturing (CMC) · Supplement 2AP
1984-01-13Manufacturing (CMC) · Supplement 1AP
1982-07-09OriginalAP
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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