Details for New Drug Application (NDA): 208339
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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 208339
Tradename: | ABIRATERONE ACETATE |
Applicant: | Hikma |
Ingredient: | abiraterone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 208339
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208339 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9597 | 0143-9597-21 | 120 TABLET in 1 BOTTLE (0143-9597-21) |
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208339 | ANDA | PD-Rx Pharmaceuticals, Inc. | 72789-213 | 72789-213-98 | 120 TABLET in 1 BOTTLE, PLASTIC (72789-213-98) |
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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