abiraterone Oral Tablet

Brand(s)
Zytiga
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Janssen Biotech, Inc. (2015-05-27)
Oldest Current Product
2011-04-28
License(s)
NDA
RxNORM
ORAL TABLET\ABIRATERONE
FDAOB
ORAL\TABLET\ABIRATERONE ACETATE
SPL Active
ORAL\TABLET\ABIRATERONE ACETATE
SPL Moiety
ORAL\TABLET\ABIRATERONE

product(s) by strength(s)

abiraterone acetate 250 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1578940150ZytigaNDAJanssen Biotech, Inc.2011-04-28ABIRATERONE ACETATEORALTABLETNDA2023794e338e89-3cf2-48eb-b6e2-a06c608c6513

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA202379ZYTIGAJANSSEN BIOTECH INC2011-04-28p8822438, USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAD RECEIVED PRIOR DOCETAXEL CHEMOTHERAPY/ USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
p5604213, USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER/ USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE RECEIVED PRIOR CHEMOTHERAPY CONTAINING DOCETAXEL, SUBSTANCE
NEW CHEMICAL ENTITY [2016-04-28]
IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER [2015-12-10]
NDA202379_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202379_001RXABIRATERONE ACETATE (250MG)ORALTABLETTrue2011-04-28ZYTIGA

patent(s)

#idexpiration dateapplication(s)
1p5604213 (view patent)2016-12-13NDA202379
2p8822438 (view patent)2027-08-24NDA202379

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14e338e89-3cf2-48eb-b6e2-a06c608c6513 (view SPL)These highlights do not include all the information needed to use ZYTIGA safely and effectively. See full prescribing information for ZYTIGA. ZYTIGA (abiraterone acetate) Tablets For Oral Administration Initial U.S. Approval: 2011prescriptionHuman PrescriptionJanssen Biotech, Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-05-2716578940150

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII