Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 202107
Company: CORCEPT THERAP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KORLYM MIFEPRISTONE 300MG TABLET;ORAL Prescription AB Yes Yes
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-Package Insert, Labeling-Medication Guide, 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.

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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/202107s007lbl.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
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

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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