← FDA DRUG APPROVALS

FDA ANDA · ANDA074286

DESOXIMETASONE

Sponsor: TARO

APPLICATION
ANDA074286
TYPE
ANDA
ORIGINAL APPROVAL
1996-06-07
LATEST ACTION
2015-04-15
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

TOPICORTDiscontinued
DESOXIMETASONE 0.25% · OINTMENT · TOPICAL

Approval history

2015-04-15Labeling · Supplement 15AP
2013-03-20Labeling · Supplement 17 — Label ↗AP
2010-03-15Manufacturing (CMC) · Supplement 16 — Review ↗AP
2008-07-25Manufacturing (CMC) · Supplement 13 — Review ↗AP
2008-07-25Manufacturing (CMC) · Supplement 12 — Review ↗AP
2005-09-15Manufacturing (CMC) · Supplement 10 — Review ↗AP
2004-11-23Labeling · Supplement 9 — Review ↗AP
2004-04-26Manufacturing (CMC) · Supplement 7 — Review ↗AP
2004-04-26Labeling · Supplement 8 — Review ↗AP
2003-12-19Labeling · Supplement 6 — Review ↗AP
2000-05-16Manufacturing (CMC) · Supplement 4 — Review ↗AP
1999-04-09Manufacturing (CMC) · Supplement 3 — Review ↗AP
1997-07-18Manufacturing (CMC) · Supplement 2 — Review ↗AP
1996-09-17Manufacturing (CMC) · Supplement 1 — Review ↗AP
1996-06-07OriginalAP
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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