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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 213433

WINLEVI (CLASCOTERONE)
1%
Marketing Status: Prescription
Active Ingredient: CLASCOTERONE
Proprietary Name: WINLEVI
Dosage Form; Route of Administration: CREAM; TOPICAL
Strength: 1%
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N213433
Product Number: 001
Approval Date: Aug 26, 2020
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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