← FDA DRUG APPROVALS

FDA NDA · NDA213433

WINLEVI

clascoterone

Sponsor: SUN PHARM

APPLICATION
NDA213433
TYPE
NDA
ORIGINAL APPROVAL
2020-08-26
LATEST ACTION
2022-03-18
ROUTE
TOPICAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

WINLEVI · ReferencePrescription
CLASCOTERONE 1% · CREAM · TOPICAL

Approval history

2022-03-18Labeling · Supplement 2 · standard — Letter ↗AP
2021-08-19Supplement · Supplement 1 · standardAP
2020-08-26Type 1 - New Molecular Entity · Original · standard — Letter ↗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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