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Drugs@FDA: FDA-Approved Drugs

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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
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
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