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FDA NDA · NDA018586

TOPICORT

Sponsor: TARO

APPLICATION
NDA018586
TYPE
NDA
ORIGINAL APPROVAL
1982-03-29
LATEST ACTION
2004-04-27
ROUTE
TOPICAL
DOSAGE FORM
GEL
MARKETING STATUS
Discontinued

Products

TOPICORT · ReferenceDiscontinued
DESOXIMETASONE 0.05% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · GEL · TOPICAL

Approval history

2004-04-27Labeling · Supplement 4 — Letter ↗AP
1998-09-15Manufacturing (CMC) · Supplement 10 · standardAP
1996-05-22Manufacturing (CMC) · Supplement 8 · standardAP
1996-01-25Manufacturing (CMC) · Supplement 7 · standardAP
1994-07-26Manufacturing (CMC) · Supplement 6 · standardAP
1993-10-13Manufacturing (CMC) · Supplement 5 · standardAP
1991-09-25Manufacturing (CMC) · Supplement 3 · standardAP
1989-11-16Manufacturing (CMC) · Supplement 2 · standardAP
1983-08-30Manufacturing (CMC) · Supplement 1 · standardAP
1982-03-29Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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