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FDA Drug Application 019884 by BAXTER HLTHCARE

Application Number019884
Application Type New Drug Application
Sponsor ApplicantBAXTER HLTHCARE
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
AP012/30/1988N       
AP011/16/1994SCS       
AP04/22/1993SCM       
AP05/23/1996SCS       
AP09/25/1995SLR       
AP07/26/2000SCS       
AP01/30/2003SLR4771007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19884slr007,008ltr.pdf 1/30/2003
AP01/30/2003SLR4772008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19884slr007,008ltr.pdf 1/30/2003
AP03/17/2014SLR38821013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019884Orig1s013,020855Orig1s002ltr.pdf 3/19/2014
AP03/17/2014SLR38841013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019884s013lbl.pdf 3/19/2014
AP02/26/2016SCM       




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