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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. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ZYTIGA profile page.

The generic ingredient in ZYTIGA is abiraterone acetate. There are twenty drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the abiraterone acetate profile page.

Summary for NDA: 202379

Tradename:
ZYTIGA
Applicant:
Janssen Biotech
Ingredient:
abiraterone acetate
Patents:2
Formulation / Manufacturing:see details

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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength250MG
Approval Date:Apr 28, 2011TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 10, 2015
Regulatory Exclusivity Use:IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
Regulatory Exclusivity Expiration:Apr 28, 2016
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Patent:5,604,213Patent Expiration:Dec 13, 2016Product Flag?YSubstance Flag?YDelist Request?
Patented Use:USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER


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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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