enzalutamide Oral Capsule

Brand(s)
Xtandi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Fujisawa Healthcare, Inc. (2015-10-07)
Oldest Current Product
2012-08-31
License(s)
NDA
RxNORM
ORAL CAPSULE\ENZALUTAMIDE
FDAOB
ORAL\CAPSULE\ENZALUTAMIDE
SPL Active
ORAL\CAPSULE\ENZALUTAMIDE
SPL Moiety
ORAL\CAPSULE\ENZALUTAMIDE

product(s) by strength(s)

enzalutamide 40 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004690125XtandiNDAFujisawa Healthcare, Inc.2012-08-31ENZALUTAMIDEORALCAPSULENDA203415b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203415XTANDIASTELLAS PHARMA US INC2012-08-31p7709517, SUBSTANCE
p9126941, THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).
p8183274, THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE PREVIOUSLY RECEIVED DOCETAXEL/ THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (CRPC).
NEW CHEMICAL ENTITY [2017-08-31]
TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-REISISTANT PROSTATE CANCER (CRPC) [2017-09-10]
NDA203415_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203415_001RXENZALUTAMIDE (40MG)ORALCAPSULETrue2012-08-31XTANDI

patent(s)

#idexpiration dateapplication(s)
1p7709517 (view patent)2027-08-13NDA203415
2p8183274 (view patent)2026-05-15NDA203415
3p9126941 (view patent)2026-05-15NDA203415

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1b129fdc9-1d8e-425c-a5a9-8a2ed36dfbdf (view SPL)These highlights do not include all the information needed to use XTANDI safely and effectively. See full prescribing information for XTANDI.XTANDI (enzalutamide) capsules for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionFujisawa Healthcare, Inc.2015-10-077004690125

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