Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020687
Company: DANCO LABS LLC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MIFEPREX MIFEPRISTONE 200MG 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
09/28/2000 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20687_mifepristone.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
08/05/2016 SUPPL-23 Manufacturing (CMC)

Label is not available on this site.

04/11/2019 SUPPL-22 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020687s022lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020687Orig1s022ltr.pdf
03/10/2016 SUPPL-21 Manufacturing (CMC)

Label is not available on this site.

03/29/2016 SUPPL-20 Efficacy-New Dosing Regimen Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020687Orig1s020ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/020687Orig1s020TOC.cfm
03/26/2013 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/24/2009 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020687s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020687s015ltr.pdf
06/08/2011 SUPPL-14 Labeling, REMS-Proposal Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020687s014ltr.pdf
07/19/2005 SUPPL-13 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020687s013ltr.pdf
12/22/2004 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20687s011ltr.pdf
11/15/2004 SUPPL-10 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020687s010-lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20687s010ltr.pdf
03/29/2002 SUPPL-1 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/11/2019 SUPPL-22 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020687s022lbl.pdf
03/29/2016 SUPPL-20 Efficacy-New Dosing Regimen Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf
06/08/2011 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf
06/08/2011 SUPPL-14 REMS-Proposal Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf
04/24/2009 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020687s015lbl.pdf
07/19/2005 SUPPL-13 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf
11/15/2004 SUPPL-10 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020687s010-lbl.pdf
09/28/2000 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.pdf

MIFEPREX

TABLET;ORAL; 200MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
MIFEPREX MIFEPRISTONE 200MG TABLET;ORAL Prescription Yes AB 020687 DANCO LABS LLC
MIFEPRISTONE MIFEPRISTONE 200MG TABLET;ORAL Prescription No AB 091178 GENBIOPRO

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