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FDA ANDA · ANDA040122

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: WATSON LABS

APPLICATION
ANDA040122
TYPE
ANDA
ORIGINAL APPROVAL
1996-03-04
LATEST ACTION
2002-03-27
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · TABLET · ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 750MG, HYDROCODONE BITARTRATE 7.5MG · TABLET · ORAL

Approval history

2002-03-27Manufacturing (CMC) · Supplement 5AP
2000-03-21Manufacturing (CMC) · Supplement 4AP
1998-08-21Manufacturing (CMC) · Supplement 3AP
1997-07-08Manufacturing (CMC) · Supplement 1AP
1996-03-04OriginalAP
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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