Details for New Drug Application (NDA): 208416
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The generic ingredient in ABIRATERONE ACETATE is abiraterone acetate. There are twenty-five drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
Summary for 208416
Tradename: | ABIRATERONE ACETATE |
Applicant: | Dr Reddys |
Ingredient: | abiraterone acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208416
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208416 | ANDA | NorthStar Rx LLC | 16714-963 | 16714-963-01 | 120 TABLET in 1 BOTTLE (16714-963-01) |
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208416 | ANDA | Dr. Reddys Laboratories Inc | 43598-358 | 43598-358-04 | 120 TABLET in 1 BOTTLE (43598-358-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | May 18, 2020 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Sep 1, 2023 | TE: | AB | RLD: | No |
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