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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202107
Company: CORCEPT THERAP

Medication Guide

Summary Review

Products on NDA 202107

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KORLYM	MIFEPRISTONE	300MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 202107

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/17/2012	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	STANDARD; Orphan	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202107s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202107s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107_korlym_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2019	SUPPL-8	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202107s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/202107Orig1s008ltr.pdf
05/16/2017	SUPPL-7	Labeling-Medication Guide, Labeling-Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/202107Orig1s007ltr.pdf
10/25/2016	SUPPL-6	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202107s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202107Orig1s006ltr.pdf
07/22/2015	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
07/29/2014	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
07/28/2014	SUPPL-3	Manufacturing (CMC)		Label is not available on this site.
10/03/2013	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 202107

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
11/05/2019	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/202107s008lbl.pdf
05/16/2017	SUPPL-7	Labeling-Medication Guide	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf
05/16/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf
05/16/2017	SUPPL-7	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.pdf
10/25/2016	SUPPL-6	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202107s006lbl.pdf
02/17/2012	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202107s000lbl.pdf

Therapeutic Equivalents for NDA 202107

KORLYM

TABLET;ORAL; 300MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
KORLYM	MIFEPRISTONE	300MG	TABLET;ORAL	Prescription	Yes	AB	202107	CORCEPT THERAP
MIFEPRISTONE	MIFEPRISTONE	300MG	TABLET;ORAL	Prescription	No	AB	211436	TEVA PHARMS USA INC

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