Details for New Drug Application (NDA): 202379

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NDA 202379 describes ZYTIGA, which is a drug marketed by Janssen Biotech and is included in one NDA. It is available from one supplier. Additional details are available on the ZYTIGA profile page.

The generic ingredient in ZYTIGA 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 202379

Tradename:	ZYTIGA
Applicant:	Janssen Biotech
Ingredient:	abiraterone acetate
Patents:	0

Pharmacology for NDA: 202379

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

Medical Subject Heading (MeSH) Categories for 202379

Antineoplastic Agents
Cytochrome P-450 Enzyme Inhibitors
Steroid Synthesis Inhibitors

Suppliers and Packaging for NDA: 202379

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ZYTIGA	abiraterone acetate	TABLET;ORAL	202379	NDA	Janssen Biotech, Inc.	57894-150	57894-150-12	120 TABLET in 1 BOTTLE (57894-150-12)
ZYTIGA	abiraterone acetate	TABLET;ORAL	202379	NDA	Janssen Biotech, Inc.	57894-195	57894-195-06	60 TABLET, FILM COATED in 1 BOTTLE (57894-195-06)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	250MG
Approval Date:	Apr 28, 2011	TE:	AB	RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	500MG
Approval Date:	Apr 14, 2017	TE:	AB	RLD:	Yes

Expired US Patents for NDA 202379

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Biotech	ZYTIGA	abiraterone acetate	TABLET;ORAL	202379-001	Apr 28, 2011	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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