Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 202107
Company: CORCEPT THERAP
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-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. |
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 |
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 |