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FDA Drug Application 020221 by CLINIGEN HLTHCARE

Application Number020221
Application Type New Drug Application
Sponsor ApplicantCLINIGEN HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/8/1995N       
AP01/23/1996SCS       
AP03/15/1996SE1       
AP012/30/1996SCS       
AP011/21/1996SCM       
AP012/18/1996SCM       
AP02/20/1997SCS       
AP010/10/1997SCM       
AP03/11/1999SLR       
AP02/11/1999SCS       
AP06/24/1999SE11174012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20221s12ltr.pdf 6/24/1999
AP06/24/1999SE11175012   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20221s12lbl.pdf 6/24/1999
AP06/24/1999SE11815012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20221-S012_Ethyol.cfm 6/24/1999
AP04/1/1999SLR       
AP09/10/1999SCS       
AP02/20/2002SLR1814015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20221s15ltr.pdf 2/20/2002
AP03/27/2003SLR4654017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20221slr017_ethyol_lbl.pdf 3/28/2003
AP03/27/2003SLR5277017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20221slr017ltr.pdf 4/15/2003
AP03/28/2006SLR13850020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020221s020ltr.pdf 4/5/2006
AP011/7/2008SLR21208024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020221s024lbl.pdf 11/12/2008
AP011/7/2008SLR21222024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020221s024ltr.pdf 11/13/2008
AP08/26/2013SCM       
AP03/9/2016SCM       
AP01/15/2016SCM       




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