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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 210308

YONSA (ABIRATERONE ACETATE)
125MG
Marketing Status: Prescription
Active Ingredient: ABIRATERONE ACETATE
Proprietary Name: YONSA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 125MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N210308
Product Number: 001
Approval Date: May 22, 2018
Applicant Holder Full Name: SUN PHARMACEUTICAL INDUSTRIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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