← FDA DRUG APPROVALS

FDA ANDA · ANDA081051

HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Sponsor: MIKART

APPLICATION
ANDA081051
TYPE
ANDA
ORIGINAL APPROVAL
1992-08-28
LATEST ACTION
2004-01-13
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND ACETAMINOPHENDiscontinued
ACETAMINOPHEN 500MG/15ML, HYDROCODONE BITARTRATE 7.5MG/15ML · SOLUTION · ORAL

Approval history

2004-01-13Supplement · Supplement 21 — Review ↗AP
2002-12-12Labeling · Supplement 20 — Review ↗AP
2002-08-13Manufacturing (CMC) · Supplement 18 — Review ↗AP
2001-04-17Labeling · Supplement 8 — Review ↗AP
1999-10-27Manufacturing (CMC) · Supplement 16 — Review ↗AP
1999-10-27Manufacturing (CMC) · Supplement 17 — Review ↗AP
1998-07-31Manufacturing (CMC) · Supplement 15 — Review ↗AP
1997-10-01Labeling · Supplement 13 — Review ↗AP
1997-10-01Manufacturing (CMC) · Supplement 11 — Review ↗AP
1997-10-01Manufacturing (CMC) · Supplement 9 — Review ↗AP
1997-10-01Manufacturing (CMC) · Supplement 12 — Review ↗AP
1997-01-29Labeling · Supplement 1 — Review ↗AP
1996-07-24Labeling · Supplement 14 — Review ↗AP
1996-03-06Labeling · Supplement 3 — Review ↗AP
1996-03-06Labeling · Supplement 4 — Review ↗AP
1996-01-18Manufacturing (CMC) · Supplement 7 — Review ↗AP
1995-07-25Manufacturing (CMC) · Supplement 5 — Review ↗AP
1995-06-08Labeling · Supplement 6 — Review ↗AP
1995-03-02Manufacturing (CMC) · Supplement 2 — Review ↗AP
1992-08-28Original — 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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