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FDA Drug Application 020666 by AMEDRA PHARMS LLC

Application Number020666
Application Type New Drug Application
Sponsor ApplicantAMEDRA PHARMS LLC
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
AP06/11/1996N       
AP08/20/2007SLR17657004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020666s004lbl.pdf 8/21/2007
AP08/20/2007SLR17682004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020666s004ltr.pdf 8/22/2007
AP010/20/2009SLR23650005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf 10/21/2009
AP010/20/2009SLR23972005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf 11/19/2009
AP010/20/2009SLR23973006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020666s005,s006ltr.pdf 11/19/2009
AP010/20/2009SLR23651006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020666s005s006lbl.pdf 10/21/2009
AP06/11/2015SLR43052009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020666Orig1s009ltr.pdf 6/12/2015
AP06/11/2015SLR43056009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020666s009lbl.pdf 6/12/2015




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