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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020687
Company: DANCO LABS LLC

Medication Guide

Summary Review

REMS

Original REMS Approved in 2011

Other Important Information from FDA

Products on NDA 020687

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
MIFEPREX	MIFEPRISTONE	200MG	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020687

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
03/23/2023	SUPPL-26	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020687Orig1s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020687Orig1s026ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020687Orig1s026.pdf
01/03/2023	SUPPL-25	REMS - MODIFIED - D-N-A	Label (PDF) Letter (PDF) Review (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020687Orig1s025Lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020687Orig1s025ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2023/020687Orig1s025.pdf https://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2023/020687Orig1s025SumR.pdf
05/14/2021	SUPPL-24	REMS - MODIFIED - D-N-A	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020687Orig1s024ltr.pdf
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	REMS-Proposal, Labeling	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.

Labels for NDA 020687

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
03/23/2023	SUPPL-26	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020687Orig1s026lbl.pdf
01/03/2023	SUPPL-25	REMS - MODIFIED - D-N-A	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020687Orig1s025Lbl.pdf
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	REMS-Proposal	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf
06/08/2011	SUPPL-14	Labeling	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

Therapeutic Equivalents for NDA 020687

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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