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FDA Drug Application 020068 by CLINIGEN HLTHCARE

Application Number020068
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 Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/27/1991N       
AP012/12/1995SLR       
AP06/16/1995SE1       
AP011/17/1995SLR       
AP01/24/1997SE1       
AP01/24/1997SE2       
AP01/24/1997SLR       
AP03/31/1997SLR       
AP01/3/1997SCS       
AP011/16/1998SCS       
AP06/13/2000SLR       
AP06/13/2000SLR       
AP05/15/2006SLR14096016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020068s016lbl.pdf 5/16/2006
AP05/15/2006SLR14123016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020068s016LTR.pdf 5/18/2006
AP011/27/2007SLR18612017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020068s017lbl.pdf 12/3/2007
AP02/10/2012SCM32359018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020068s018lbl.pdf 4/6/2012
AP06/10/2014SCM       
AP011/7/2014SLR40979020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020068Orig1s020ltr.pdf 11/12/2014
AP011/7/2014SLR42732020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020068s020lbl.pdf 5/5/2015
AP05/29/2015SCM       




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