Details for New Drug Application (NDA): 210686
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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 210686
Tradename: | ABIRATERONE ACETATE |
Applicant: | Msn |
Ingredient: | abiraterone acetate |
Patents: | 0 |
Suppliers and Packaging for NDA: 210686
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 210686 | ANDA | BluePoint Laboratories | 68001-489 | 68001-489-07 | 120 TABLET in 1 BOTTLE (68001-489-07) |
ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 210686 | ANDA | MSN LABORATORIES PRIVATE LIMITED | 69539-049 | 69539-049-92 | 120 TABLET in 1 BOTTLE (69539-049-92) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
Approval Date: | Jul 10, 2019 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
Approval Date: | Apr 24, 2024 | TE: | AB | RLD: | No |
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