regorafenib Oral Tablet

Brand(s)
Stivarga
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Bayer Healthcare Pharmaceuticals Inc. (2015-04-13)
Oldest Current Product
2012-09-27
License(s)
NDA
RxNORM
ORAL TABLET\REGORAFENIB
FDAOB
ORAL\TABLET\REGORAFENIB
SPL Active
ORAL\TABLET, FILM COATED\REGORAFENIB MONOHYDRATE
SPL Moiety
ORAL\TABLET, FILM COATED\REGORAFENIB

product(s) by strength(s)

regorafenib 40 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1504190171StivargaNDABayer Healthcare Pharmaceuticals Inc.2012-09-27REGORAFENIB MONOHYDRATEORALTABLET, FILM COATEDNDA203085824f19c9-0546-4a8a-8d8f-c4055c04f7c7

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203085STIVARGABAYER HEALTHCARE PHARMACEUTICALS INC2012-09-27p7351834
p8637553, SUBSTANCE
p8680124, TREATMENT OF PATIENTS WITH GASTROINTESTINAL STROMAL TUMOR (GIST)
ORPHAN DRUG EXCLUSIVITY [2020-02-25]
TREATMENT OF PATIENTS WITH LOCALLY ADVANCED [2016-02-25]
NEW CHEMICAL ENTITY [2017-09-27]
NDA203085_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203085_001RXREGORAFENIB (40MG)ORALTABLETTrue2012-09-27STIVARGA

patent(s)

#idexpiration dateapplication(s)
1p7351834 (view patent)2020-01-12NDA203085, NDA021923
2p8637553 (view patent)2031-02-16NDA203085
3p8680124 (view patent)2030-06-02NDA203085

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
1824f19c9-0546-4a8a-8d8f-c4055c04f7c7 (view SPL)These highlights do not include all the information needed to use STIVARGA safely and effectively. See full prescribing information for STIVARGA. STIVARGA (regorafenib) tablets, for oral useInitial U.S. Approval: 2012prescriptionHuman PrescriptionBayer Healthcare Pharmaceuticals Inc.MANUFACTURE2015-04-1314504190171

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