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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 208380

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NDA 208380 describes ABIRATERONE ACETATE, which is a drug marketed by Amneal Pharms, Apotex, Dr Reddys, Glenmark Speclt, Hikma, MSN, Mylan, Novugen, Qilu, Regcon Holdings, Rising, Teva Pharms Usa, and Wockhardt Bio Ag, and is included in fifteen NDAs. It is available from twenty 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-three suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.

Summary for 208380

Tradename:	ABIRATERONE ACETATE
Applicant:	Wockhardt Bio Ag
Ingredient:	abiraterone acetate
Patents:	0

Medical Subject Heading (MeSH) Categories for 208380

Antineoplastic Agents
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Feb 27, 2019	TE:	AB	RLD:	No

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