Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 202379

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ZYTIGA (ABIRATERONE ACETATE)
250MG
Marketing Status: Prescription

Active Ingredient: ABIRATERONE ACETATE
Proprietary Name: ZYTIGA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: Yes
Reference Standard: No
TE Code: AB
Application Number: N202379
Product Number: 001
Approval Date: Apr 28, 2011
Applicant Holder Full Name: JANSSEN BIOTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information

ZYTIGA (ABIRATERONE ACETATE)
500MG
Marketing Status: Prescription

Active Ingredient: ABIRATERONE ACETATE
Proprietary Name: ZYTIGA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: AB
Application Number: N202379
Product Number: 002
Approval Date: Apr 14, 2017
Applicant Holder Full Name: JANSSEN BIOTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information