FDA.reportPublic FDA data

Application 202107

Type
NDA
Sponsor
CORCEPT THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KORLYMMIFEPRISTONETABLET;ORAL300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
76346-073KorlymMifepristoneCorcept TherapeuticsNDACurrent
76346-073KorlymMifepristoneCorcept TherapeuticsNDACurrent
76346-073KorlymMifepristoneCorcept TherapeuticsNDACurrent
76346-073KorlymMifepristoneCorcept TherapeuticsNDACurrent
76346-073KorlymMifepristoneCorcept TherapeuticsNDACurrent
76346-073KorlymMifepristoneCorcept TherapeuticsNDACurrent
76346-073KorlymMifepristoneCorcept TherapeuticsNDACurrent
76346-073KorlymMifepristoneCorcept TherapeuticsNDACurrent
76346-073KorlymMifepristoneCorcept TherapeuticsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
61184SUPPL2019-12-06
61183SUPPL2019-12-06
60806SUPPL2019-11-12
48498SUPPL2017-05-23
48452SUPPL2017-05-19
48440SUPPL2017-05-18
45757SUPPL2016-11-01
45703SUPPL2016-10-28
44844ORIG2012-07-06
43385ORIG2012-07-06
9962ORIG2012-02-27
19061ORIG2012-02-22