Details for New Drug Application (NDA): 208416
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NDA 208416 describes ABIRATERONE ACETATE, which is a drug marketed by Amneal Pharms, Apotex, Dr Reddys, Florida, Glenmark Speclt, Hikma, MSN, Mylan, Novugen, Qilu, Rising, Teva Pharms Usa, and Wockhardt Bio Ag, and is included in fifteen NDAs. It is available from twenty-four suppliers. Additional details are available on the ABIRATERONE ACETATE profile page.
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.
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 208416
| Tradename: | ABIRATERONE ACETATE |
| Applicant: | Dr Reddys |
| Ingredient: | abiraterone acetate |
| Patents: | 0 |
Suppliers and Packaging for NDA: 208416
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208416 | ANDA | NorthStar Rx LLC | 16714-963 | 16714-963-01 | 120 TABLET in 1 BOTTLE (16714-963-01) |
| ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208416 | ANDA | Dr. Reddys Laboratories Inc | 43598-358 | 43598-358-04 | 120 TABLET in 1 BOTTLE (43598-358-04) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 250MG | ||||
| Approval Date: | May 18, 2020 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 500MG | ||||
| Approval Date: | Sep 1, 2023 | TE: | AB | RLD: | No | ||||
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