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FDA Drug Application 021945 by AMAG PHARMA USA

Application Number021945
Application Type New Drug Application
Sponsor ApplicantAMAG PHARMA USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/3/2011N27701000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021945s000lbl.pdf 2/3/2011
AP02/3/2011N27811000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021945s000ltr.pdf 2/10/2011
AP02/3/2011N34208000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021945_makena_toc.cfm 10/31/2012
AP02/3/2011N34209000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021945Orig1s000SumR.pdf 10/31/2012
AP09/16/2013SLR37099005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021945s005lbl.pdf 9/16/2013
AP09/16/2013SLR37135005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021945Orig1s005ltr.pdf 9/17/2013
AP07/15/2016SCM       
AP02/19/2016SCM       




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