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FDA NDA · NDA018763

TOPICORT

Sponsor: TARO

APPLICATION
NDA018763
TYPE
NDA
ORIGINAL APPROVAL
1983-10-03
LATEST ACTION
2004-04-27
ROUTE
TOPICAL
DOSAGE FORM
OINTMENT
MARKETING STATUS
Discontinued

Products

TOPICORT · ReferenceDiscontinued
DESOXIMETASONE 0.25% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · OINTMENT · TOPICAL

Approval history

2004-04-27Labeling · Supplement 3 — Label ↗AP
1998-02-18Manufacturing (CMC) · Supplement 9 · standardAP
1996-01-25Manufacturing (CMC) · Supplement 7 · standardAP
1996-01-19Manufacturing (CMC) · Supplement 6 · standardAP
1994-07-26Manufacturing (CMC) · Supplement 5 · standardAP
1993-10-13Manufacturing (CMC) · Supplement 4 · standardAP
1988-02-18Manufacturing (CMC) · Supplement 1 · standardAP
1983-10-03Type 3 - New Dosage Form · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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