Details for New Drug Application (NDA): 215947

NDA 215947 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 215947

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

Pharmacology for NDA: 215947

Mechanism of Action

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

Medical Subject Heading (MeSH) Categories for 215947

Antineoplastic Agents

Cytochrome P-450 Enzyme Inhibitors

Steroid Synthesis Inhibitors

Suppliers and Packaging for NDA: 215947

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	215947	ANDA	Novugen Pharma (USA) LLC	82293-001	82293-001-10	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82293-001-10)
ABIRATERONE ACETATE	abiraterone acetate	TABLET;ORAL	215947	ANDA	Novugen Pharma (USA) LLC	82293-002	82293-002-10	60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (82293-002-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Jan 5, 2022	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Jan 5, 2022	TE:	AB	RLD:	No

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