Details for New Drug Application (NDA): 210308
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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: | ⤷ Sign Up | 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: | ⤷ Sign Up | Patent Expiration: | Mar 17, 2034 | Product Flag? | Y | Substance Flag? | Delist Request? |
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