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FDA Drug Application 020687 by DANCO LABS LLC

Application Number020687
Application Type New Drug Application
Sponsor ApplicantDANCO LABS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/28/2000N128000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20687appltr.pdf 9/28/2000
AP09/28/2000N129000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20687_mifepristone.cfm 9/28/2000
AP09/28/2000N130000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20687lbl.pdf 9/28/2000
AP09/28/2000N15085000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111323.htm 10/12/2006
AP09/28/2000N24016000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088643.pdf 11/19/2009
AP03/29/2002SCE       
AP011/15/2004SLR10582010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020687s010-lbl.pdf 11/15/2004
AP011/15/2004SLR10583010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20687s010ltr.pdf 11/15/2004
AP012/22/2004SLR10819011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20687s011ltr.pdf 12/29/2004
AP07/19/2005SLR12024013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020687s013lbl.pdf 7/19/2005
AP07/19/2005SLR12028013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020687s013ltr.pdf 7/21/2005
AP06/8/2011SLR29070014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020687s014ltr.pdf 6/9/2011
AP06/8/2011SLR29106014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020687s014lbl.pdf 6/10/2011
AP06/8/2011SLR45556014REMS approved 6/8/2011  http://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifeprex_2011-06-08_Full.pdf 3/30/2016
AP04/27/2009SLR28558015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020687s015MedG.pdf 4/18/2011
AP04/27/2009SLR22330015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020687s015lbl.pdf 4/28/2009
AP04/27/2009SLR22431015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020687s015ltr.pdf 5/6/2009
AP03/26/2013SCM       
AP03/29/2016SE245557020REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=35 3/30/2016
AP03/29/2016SE245558020   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088643.pdf 3/30/2016
AP03/29/2016SE245540020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020687s020lbl.pdf 3/30/2016
AP03/29/2016SE245541020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020687Orig1s020ltr.pdf 3/30/2016
AP03/10/2016SCM       
AP08/5/2016SCM       




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