Details for New Drug Application (NDA): 210308

NDA 210308 describes YONSA, which is a drug marketed by Sun Pharm and is included in one NDA. It is available from two suppliers. 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-three 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

Pharmacology for NDA: 210308

Mechanism of Action

Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors

Medical Subject Heading (MeSH) Categories for 210308

Antineoplastic Agents

Cytochrome P-450 Enzyme Inhibitors

Steroid Synthesis Inhibitors

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)
YONSA	abiraterone acetate	TABLET;ORAL	210308	NDA	Golden State Medical Supply, Inc.	51407-503	51407-503-12	120 TABLET in 1 BOTTLE, PLASTIC (51407-503-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	125MG
Approval Date:	May 22, 2018	TE:		RLD:	Yes
Patent:		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:		Patent Expiration:	Mar 17, 2034	Product Flag?	Y	Substance Flag?		Delist Request?

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