Details for New Drug Application (NDA): 210726
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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 210726
Tradename: | ABIRATERONE ACETATE |
Applicant: | Teva Pharms Usa |
Ingredient: | abiraterone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 210726
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 210726 | ANDA | Actavis Pharma, Inc. | 0591-4365 | 0591-4365-60 | 60 TABLET, FILM COATED in 1 BOTTLE (0591-4365-60) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jan 26, 2023 | TE: | AB | RLD: | No |
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