Details for New Drug Application (NDA): 210308
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NDA 210308 describes YONSA, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from one supplier. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the YONSA profile page.
The generic ingredient in YONSA 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 YONSA 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 210308
| Tradename: | YONSA |
| Applicant: | Sun Pharm |
| Ingredient: | abiraterone acetate |
| Patents: | 2 |
Suppliers and Packaging for NDA: 210308
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| YONSA | abiraterone acetate | TABLET;ORAL | 210308 | NDA | Sun Pharmaceutical Industries, Inc. | 47335-401 | 47335-401-81 | 120 TABLET in 1 BOTTLE, PLASTIC (47335-401-81) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 125MG | ||||
| Approval Date: | May 22, 2018 | TE: | RLD: | Yes | |||||
| Patent: | 10,292,990 | Patent Expiration: | May 20, 2034 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | USE IN COMBINATION WITH METHYLPREDNISOLONE FOR THE TREATMENT OF PATIENTS WITH PROSTATE CANCER | ||||||||
| Patent: | 9,889,144 | Patent Expiration: | Mar 17, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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