NDC 47335-994

Winlevi

Clascoterone

Winlevi is a Topical Cream in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Clascoterone.

Product ID47335-994_63830f72-8b5c-4a06-bbf6-a4138c93bec7
NDC47335-994
Product TypeHuman Prescription Drug
Proprietary NameWinlevi
Generic NameClascoterone
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2021-10-04
Marketing CategoryNDA /
Application NumberNDA213433
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameCLASCOTERONE
Active Ingredient Strength1 g/100g
Pharm ClassesAndrogen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 47335-994-36

1 TUBE in 1 CARTON (47335-994-36) > 60 g in 1 TUBE
Marketing Start Date2021-10-04
NDC Exclude FlagN
Sample Package?N

Drug Details


Trademark Results [Winlevi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
WINLEVI
WINLEVI
88517589 not registered Live/Pending
CASSIOPEA S.P.A.
2019-07-16
WINLEVI
WINLEVI
86620123 5234655 Live/Registered
CASSIOPEA SPA
2015-05-05
WINLEVI
WINLEVI
86592424 5230186 Live/Registered
CASSIOPEA SPA
2015-04-09

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.