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Drug Approval Package: Korlym (mifepristone) NDA #202107
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`Page 1 of 2
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`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107_korlym_toc.cfm
`
`1 capture
`5 Apr 2016
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`Go MAR APR MAY
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`2015 2016 2017
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`(cid:66) ⍰ ❎
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`▾ About this capture
`
`FDA Home3 Drugs4 Drug Approvals and Databases5 Drugs@FDA6
`Drug Approval Package
`
`Korlym (mifepristone) Tablets, 300 mg
`Company: Corcept Therapeutics
`Application No.: 202107
`Approval Date: 02/17/2012
`Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance.
`• Approval Letter(s) (PDF)
`• Summary Review (PDF)
`• Officer/Employee List (PDF)
`• Cross Discipline Team Leader Review (PDF)
`• Printed Labeling (PDF)
`• Medical Review(s) (PDF)
`• Chemistry Review(s) (PDF)
`• Pharmacology Review(s) (PDF)
`• Proprietary Name Review(s) (PDF)
`• Clinical Pharmacology Biopharmaceutics Review(s) (PDF)
`• Risk Assessment and Risk Mitigation Review (PDF)
`• Statistical Review (PDF)
`• Other Review(s) (PDF)
`• Administrative Document(s) & Correspondence (PDF)
`
`Date created: July 6, 2012
`
`Back to Top Drugs@FDA7
`Vision impaired people having problems accessing certain pages of a PDF file may call (301) 796-3634 for assistance.
`Note: Documents in PDF format require the Adobe Acrobat Reader®8.
`
`Links on this page:
`1. https://web.archive.org/web/20160405152243/http://www.addthis.com/bookmark.php?
`u508=true&v=152&username=fdamain
`2. https://web.archive.org/web/20160405152243/http://www.addthis.com/bookmark.php
`3. https://web.archive.org/web/20160405152243/http://www.fda.gov/default.htm
`4. https://web.archive.org/web/20160405152243/http://www.fda.gov/Drugs/default.htm
`5. https://web.archive.org/web/20160405152243/http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`6. https://web.archive.org/web/20160405152243/http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`7. https://web.archive.org/web/20160405152243/http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`8. https://web.archive.org/web/20160405152243/http://get.adobe.com/reader/
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`Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
`Accessibility Contact FDA Careers FDA Basics FOIA No FEAR Act Site Map Transparency Website Policies
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`U.S. Food and Drug Administration
`10903 New Hampshire Avenue
`Silver Spring, MD 20993
`Ph. 1-888-INFO-FDA (1-888-463-6332)
`Contact FDA
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`For Government For Press
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`https://web.archive.org/web/20160405152243/https://www.accessdata.fda.gov/drugsatfda_d...
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`5/6/2019
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`1
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`TEVA1048
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`Drug Approval Package: Korlym (mifepristone) NDA #202107
`
`Page 2 of 2
`
`https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202107_korlym_toc.cfm
`
`1 capture
`5 Apr 2016
`
`Go MAR APR MAY
`05
`2015 2016 2017
`
`(cid:66) ⍰ ❎
`f (cid:64)
`▾ About this capture
`
`Links on this page:
`1. https://web.archive.org/web/20160405152243/http://www.addthis.com/bookmark.php?
`u508=true&v=152&username=fdamain
`2. https://web.archive.org/web/20160405152243/http://www.addthis.com/bookmark.php
`3. https://web.archive.org/web/20160405152243/http://www.fda.gov/default.htm
`4. https://web.archive.org/web/20160405152243/http://www.fda.gov/Drugs/default.htm
`5. https://web.archive.org/web/20160405152243/http://www.fda.gov/Drugs/InformationOnDrugs/default.htm
`6. https://web.archive.org/web/20160405152243/http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`7. https://web.archive.org/web/20160405152243/http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
`8. https://web.archive.org/web/20160405152243/http://get.adobe.com/reader/
`
`https://web.archive.org/web/20160405152243/https://www.accessdata.fda.gov/drugsatfda_d...
`
`5/6/2019
`
`2
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