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FDA ANDA · ANDA089736

VICODIN ES

Sponsor: ABBVIE

APPLICATION
ANDA089736
TYPE
ANDA
ORIGINAL APPROVAL
1988-12-09
LATEST ACTION
2006-12-26
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

VICODIN ESDiscontinued
ACETAMINOPHEN 750MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL

Approval history

2006-12-26Labeling · Supplement 13 — Label ↗AP
2001-04-02Manufacturing (CMC) · Supplement 12AP
2000-06-27Manufacturing (CMC) · Supplement 11AP
2000-03-16Manufacturing (CMC) · Supplement 10AP
1999-03-25Manufacturing (CMC) · Supplement 9AP
1992-09-28Labeling · Supplement 8AP
1991-07-17Labeling · Supplement 1AP
1991-07-17Manufacturing (CMC) · Supplement 6AP
1991-07-17Manufacturing (CMC) · Supplement 4AP
1991-07-17Manufacturing (CMC) · Supplement 2AP
1991-07-17Labeling · Supplement 7AP
1991-07-17Manufacturing (CMC) · Supplement 5AP
1991-07-17Manufacturing (CMC) · Supplement 3AP
1988-12-09Original — Review ↗AP
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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