Mifepristone Oral Tablet

Brand(s)
Korlym
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Corcept Therapeutics Inc (2015-06-18)
Oldest Current Product
2012-02-17
License(s)
NDA
RxNORM
ORAL TABLET\MIFEPRISTONE
FDAOB
ORAL\TABLET\MIFEPRISTONE
SPL Active
ORAL\TABLET\MIFEPRISTONE
SPL Moiety
ORAL\TABLET\MIFEPRISTONE

product(s) by strength(s)

mifepristone 300 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1763460073KorlymNDACorcept Therapeutics Inc2012-02-17MIFEPRISTONEORALTABLETNDA202107542f3fae-8bc8-4f00-9228-e4b66c9ad6a9

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA020687MIFEPREXDANCO LABORATORIES LLC2000-09-28NDA020687_001
2NDA202107KORLYMCORCEPT THERAPEUTICS INC2012-02-17p8921348, TREATING CUSHING'S SYNDROMEORPHAN DRUG EXCLUSIVITY [2019-02-17]
NEW PRODUCT [2015-02-17]
NDA202107_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA020687_001RXMIFEPRISTONE (200MG)ORALTABLETTrue2000-09-28MIFEPREX
2NDA202107_001RXMIFEPRISTONE (300MG)ORALTABLETTrue2012-02-17KORLYM

patent(s)

#idexpiration dateapplication(s)
1p8921348 (view patent)2028-08-27NDA202107

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1542f3fae-8bc8-4f00-9228-e4b66c9ad6a9 (view SPL)These highlights do not include all the information needed to use Korlym safely and effectively. See full prescribing information for Korlym. Korlym (mifepristone) 300 mg Tablets Initial U.S. Approval 2000prescriptionHuman PrescriptionCorcept Therapeutics Inc2015-06-185763460073

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