← FDA DRUG APPROVALS

FDA ANDA · ANDA088058

VICODIN

Sponsor: ABBVIE

APPLICATION
ANDA088058
TYPE
ANDA
ORIGINAL APPROVAL
1983-01-07
LATEST ACTION
2006-12-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

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

Approval history

2006-12-26Labeling · Supplement 27 — Label ↗AP
2001-04-02Manufacturing (CMC) · Supplement 24 — Review ↗AP
2000-06-27Manufacturing (CMC) · Supplement 23 — Review ↗AP
2000-03-16Manufacturing (CMC) · Supplement 22 — Review ↗AP
2000-02-15Manufacturing (CMC) · Supplement 21 — Review ↗AP
1992-09-10Labeling · Supplement 20 — Review ↗AP
1992-08-20Labeling · Supplement 18 — Review ↗AP
1992-08-20Manufacturing (CMC) · Supplement 19 — Review ↗AP
1988-02-29Manufacturing (CMC) · Supplement 13 — Review ↗AP
1988-02-29Manufacturing (CMC) · Supplement 14 — Review ↗AP
1988-01-19Manufacturing (CMC) · Supplement 17 — Review ↗AP
1987-05-11Manufacturing (CMC) · Supplement 9 — Review ↗AP
1987-05-11Supplement · Supplement 11 — Review ↗AP
1987-05-11Supplement · Supplement 12 — Review ↗AP
1987-05-11Manufacturing (CMC) · Supplement 8 — Review ↗AP
1986-06-24Manufacturing (CMC) · Supplement 7 — Review ↗AP
1986-06-24Manufacturing (CMC) · Supplement 6 — Review ↗AP
1984-11-26Manufacturing (CMC) · Supplement 5 — Review ↗AP
1984-11-26Manufacturing (CMC) · Supplement 3 — Review ↗AP
1984-11-26Manufacturing (CMC) · Supplement 1 — Review ↗AP
1984-11-26Manufacturing (CMC) · Supplement 2 — Review ↗AP
1983-01-07OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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