Details for New Drug Application (NDA): 208327
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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 208327
Tradename: | ABIRATERONE ACETATE |
Applicant: | Amneal Pharms |
Ingredient: | abiraterone acetate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Suppliers and Packaging for NDA: 208327
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208327 | ANDA | AvKARE | 42291-024 | 42291-024-12 | 120 TABLET in 1 BOTTLE (42291-024-12) |
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208327 | ANDA | AvKARE | 42291-073 | 42291-073-60 | 60 TABLET in 1 BOTTLE (42291-073-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jan 7, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Dec 23, 2020 | TE: | AB | RLD: | No |
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