← FDA DRUG APPROVALS

FDA NDA · NDA204141

DESOXIMETASONE

Sponsor: SUN PHARMA CANADA

APPLICATION
NDA204141
TYPE
NDA
ORIGINAL APPROVAL
2013-04-11
LATEST ACTION
2021-10-07
ROUTE
TOPICAL
DOSAGE FORM
SPRAY
MARKETING STATUS
Prescription

Products

TOPICORT · ReferencePrescription
DESOXIMETASONE 0.25% · SPRAY · TOPICAL

Approval history

2021-10-07Efficacy · Supplement 9 · standard — Letter ↗AP
2015-12-16Labeling · Supplement 4 · standard — Label ↗AP
2015-09-23Manufacturing (CMC) · Supplement 3 · standardAP
2015-09-10Manufacturing (CMC) · Supplement 2 · standardAP
2014-07-18Manufacturing (CMC) · Supplement 1 · standardAP
2013-04-11Type 3 - New Dosage Form · Original · standard — Label ↗AP
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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