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FDA Drug Application 022434 by EAGLE PHARMS

Application Number022434
Application Type New Drug Application
Sponsor ApplicantEAGLE PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/29/2011N29371000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022434s000lbl.pdf 6/30/2011
AP06/29/2011N29408000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022434s000ltr.pdf 7/6/2011
AP06/29/2011N30744000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022434_argatroban_toc.cfm 11/22/2011
AP06/29/2011N30745000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022434Orig1s000SumR.pdf 11/22/2011
AP05/20/2013SCM       
AP06/10/2013SCM       
AP01/16/2014SCM       
AP09/9/2014SLR40474006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022434Orig1s006ltr.pdf 9/10/2014
AP09/9/2014SLR40477006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022434s006lbl.pdf 9/11/2014
AP08/5/2015SCM       
AP08/18/2015SCM       
AP05/25/2016SLR46179010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022434Orig1s010ltr.pdf 5/27/2016
AP05/25/2016SLR46212010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022434s010lbl.pdf 6/1/2016




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