Details for New Drug Application (NDA): 212462
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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 212462
Tradename: | ABIRATERONE ACETATE |
Applicant: | Qilu |
Ingredient: | abiraterone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 212462
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 212462 | ANDA | Apotex Corp. | 60505-4764 | 60505-4764-6 | 60 TABLET, FILM COATED in 1 BOTTLE (60505-4764-6) |
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 212462 | ANDA | Florida Pharmaceutical Products, LLC. | 71921-178 | 71921-178-20 | 120 TABLET in 1 BOTTLE (71921-178-20) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Sep 27, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Jun 25, 2021 | TE: | AB | RLD: | No |
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