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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for NDA 216793

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AKEEGA (ABIRATERONE ACETATE; NIRAPARIB TOSYLATE)
500MG;EQ 50MG BASE
Marketing Status: Prescription
Active Ingredient: ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
Proprietary Name: AKEEGA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 50MG BASE
Reference Listed Drug: Yes
Reference Standard: No
TE Code: 
Application Number: N216793
Product Number: 001
Approval Date: Aug 11, 2023
Applicant Holder Full Name: JANSSEN BIOTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
AKEEGA (ABIRATERONE ACETATE; NIRAPARIB TOSYLATE)
500MG;EQ 100MG BASE
Marketing Status: Prescription
Active Ingredient: ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
Proprietary Name: AKEEGA
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG;EQ 100MG BASE
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code: 
Application Number: N216793
Product Number: 002
Approval Date: Aug 11, 2023
Applicant Holder Full Name: JANSSEN BIOTECH INC
Marketing Status:  Prescription
Patent and Exclusivity Information
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