APPLICATION
ANDA081070
TYPE
ANDA
ORIGINAL APPROVAL
1989-11-30
LATEST ACTION
2002-08-13
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG, HYDROCODONE BITARTRATE 5MG · CAPSULE · ORAL
Approval history
2002-08-13Manufacturing (CMC) · Supplement 7AP
1998-07-31Manufacturing (CMC) · Supplement 6AP
1996-03-13Labeling · Supplement 2AP
1995-08-11Manufacturing (CMC) · Supplement 5AP
1995-03-27Manufacturing (CMC) · Supplement 4AP
1995-02-08Manufacturing (CMC) · Supplement 3AP
1993-07-12Manufacturing (CMC) · Supplement 1AP
1989-11-30OriginalAP
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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