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Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations

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Product Details for ANDA 208416

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ABIRATERONE ACETATE (ABIRATERONE ACETATE)
250MG
Marketing Status: Prescription
Active Ingredient: ABIRATERONE ACETATE
Proprietary Name: ABIRATERONE ACETATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 250MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208416
Product Number: 001
Approval Date: May 18, 2020
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
ABIRATERONE ACETATE (ABIRATERONE ACETATE)
500MG
Marketing Status: Prescription
Active Ingredient: ABIRATERONE ACETATE
Proprietary Name: ABIRATERONE ACETATE
Dosage Form; Route of Administration: TABLET; ORAL
Strength: 500MG
Reference Listed Drug: No
Reference Standard: No
TE Code: AB
Application Number: A208416
Product Number: 002
Approval Date: Sep 1, 2023
Applicant Holder Full Name: DR REDDYS LABORATORIES LTD
Marketing Status:  Prescription
Patent and Exclusivity Information
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