← FDA DRUG APPROVALS

FDA ANDA · ANDA089008

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: MIKART

APPLICATION
ANDA089008
TYPE
ANDA
ORIGINAL APPROVAL
1986-02-21
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 47AP
1998-07-31Manufacturing (CMC) · Supplement 46AP
1996-11-14Labeling · Supplement 45AP
1995-08-11Manufacturing (CMC) · Supplement 44AP
1995-03-27Manufacturing (CMC) · Supplement 43AP
1995-02-08Manufacturing (CMC) · Supplement 42AP
1992-05-13Manufacturing (CMC) · Supplement 40AP
1992-03-31Manufacturing (CMC) · Supplement 9AP
1992-03-31Manufacturing (CMC) · Supplement 6AP
1992-03-31Labeling · Supplement 10AP
1991-10-28Manufacturing (CMC) · Supplement 38AP
1991-02-13Manufacturing (CMC) · Supplement 35AP
1991-02-13Labeling · Supplement 27AP
1991-02-13Manufacturing (CMC) · Supplement 25AP
1991-02-13Manufacturing (CMC) · Supplement 23AP
1991-02-13Manufacturing (CMC) · Supplement 21AP
1991-02-13Manufacturing (CMC) · Supplement 11AP
1991-02-13Manufacturing (CMC) · Supplement 28AP
1991-02-13Manufacturing (CMC) · Supplement 26AP
1991-02-13Manufacturing (CMC) · Supplement 18AP
1991-02-13Labeling · Supplement 30AP
1991-02-13Labeling · Supplement 22AP
1991-02-13Labeling · Supplement 20AP
1991-02-13Manufacturing (CMC) · Supplement 29AP
1990-06-04Manufacturing (CMC) · Supplement 19AP
1990-06-04Manufacturing (CMC) · Supplement 39AP
1989-12-14Bioequivalence · Supplement 36AP
1989-03-09Manufacturing (CMC) · Supplement 24AP
1987-07-14Manufacturing (CMC) · Supplement 7AP
1987-07-14Manufacturing (CMC) · Supplement 3AP
1987-07-14Manufacturing (CMC) · Supplement 4AP
1986-12-23Manufacturing (CMC) · Supplement 5AP
1986-12-23Manufacturing (CMC) · Supplement 8AP
1986-05-29Manufacturing (CMC) · Supplement 1AP
1986-05-29Manufacturing (CMC) · Supplement 2AP
1986-02-21OriginalAP
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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →