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 ID: 47335-994_63830f72-8b5c-4a06-bbf6-a4138c93bec7
• NDC: 47335-994
• Product Type: Human Prescription Drug
• Proprietary Name: Winlevi
• Generic Name: Clascoterone
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2021-10-04
• Marketing Category: NDA /
• Application Number: NDA213433
• Labeler Name: Sun Pharmaceutical Industries, Inc.
• Substance Name: CLASCOTERONE
• Active Ingredient Strength: 1 g/100g
• Pharm Classes: Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

Packaging

NDC 47335-994-36

1 TUBE in 1 CARTON (47335-994-36) > 60 g in 1 TUBE

• Marketing Start Date: 2021-10-04
• NDC Exclude Flag: N
• Sample Package?: N

Drug Details