Details for New Drug Application (NDA): 208432
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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 208432
Tradename: | ABIRATERONE ACETATE |
Applicant: | Teva Pharms Usa |
Ingredient: | abiraterone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 208432
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208432 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-1125 | 0093-1125-89 | 120 TABLET, FILM COATED in 1 BOTTLE (0093-1125-89) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Oct 31, 2018 | TE: | AB | RLD: | No |
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