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FDA Drug Application 022408 by PARAPRO LLC

Application Number022408
Application Type New Drug Application
Sponsor ApplicantPARAPRO LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/18/2011N27537000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022408lbl.pdf 1/19/2011
AP01/18/2011N27554000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022408s000ltr.pdf 1/20/2011
AP01/18/2011N27891000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408sOrig1s000TOC.cfm 2/16/2011
AP01/18/2011N27893000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022408Orig1s000SumR.pdf 2/17/2011
AP012/30/2014SE841485005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022408s005lbl.pdf 1/5/2015
AP012/30/2014SE841499005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022408Orig1s005ltr.pdf 1/7/2015




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