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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 208339

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NDA 208339 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 208339

Tradename:	ABIRATERONE ACETATE
Applicant:	Hikma
Ingredient:	abiraterone acetate
Patents:	0

Pharmacology for NDA: 208339

Mechanism of Action	Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors

Medical Subject Heading (MeSH) Categories for 208339

Antineoplastic Agents
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors

Suppliers and Packaging for NDA: 208339

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208339	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9597	0143-9597-21	120 TABLET in 1 BOTTLE (0143-9597-21)
ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	208339	ANDA	PD-Rx Pharmaceuticals, Inc.	72789-213	72789-213-98	120 TABLET in 1 BOTTLE, PLASTIC (72789-213-98)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Oct 31, 2018	TE:	AB	RLD:	No

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