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FDA Drug Application 021871 by APIL

Application Number021871
Application Type New Drug Application
Sponsor ApplicantAPIL
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
AP02/17/2006N13660000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021871lbl.pdf 2/23/2006
AP02/17/2006N13691000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021871s000ltr.pdf 3/1/2006
AP02/17/2006N19523000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021871TOC.cfm 3/24/2008
AP08/22/2016SLR46851001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021871Orig1s001ltr.pdf 8/23/2016
AP08/22/2016SLR46864001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021871s001lbl.pdf 8/23/2016
AP05/1/2013SCM       
AP04/19/2016SCM       




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