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FDA Drug Application 020800 by AMEDRA PHARMS

Application Number020800
Application Type New Drug Application
Sponsor ApplicantAMEDRA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/30/2003N5860000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20800ltr.pdf 6/8/2003
AP05/30/2003N11363000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/20-800_Twinject.cfm 4/8/2005
AP05/28/2004SE58871001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20800se5-001ltr.pdf 6/1/2004
AP02/22/2005SCM11147005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20800s005ltr.pdf 2/23/2005
AP07/7/2005SLR11998006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s006ltr.pdf 7/15/2005
AP07/1/2005SCM11949007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020800s007ltr.pdf 7/8/2005
AP012/28/2006SCS15603011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020800s011ltr.pdf 1/8/2007
AP011/25/2009SCM24168018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020800s018lbl.pdf 12/2/2009
AP01/26/2011SLR27641020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020800s020lbl.pdf 1/31/2011
AP01/26/2011SLR27680020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020800s020ltr.pdf 2/3/2011
AP09/6/2013SCM37479023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/020800Orig1s023.pdf 10/21/2013
AP04/23/2014SLR39130024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s024ltr.pdf 4/24/2014
AP04/23/2014SLR39142024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800s024lbl.pdf 4/25/2014
AP03/24/2014SCM       
AP03/25/2014SCM       
AP07/25/2014SLR40020027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s027ltr.pdf 7/28/2014
AP07/25/2014SLR40047027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s027lbl.pdf 7/29/2014
AP010/23/2014SCM       
AP010/13/2014SCM       
AP010/17/2014SCM40844030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020800Orig1s030Lbl.pdf 10/21/2014
AP010/17/2014SCM40856030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020800Orig1s030ltr.pdf 10/22/2014
AP05/18/2016SLR46066034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020800Orig1s034ltr.pdf 5/19/2016
AP05/18/2016SLR46090034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020800s034lbl.pdf 5/20/2016




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