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FDA Drug Application 019157 by SETON PHARM

Application Number019157
Application Type New Drug Application
Sponsor ApplicantSETON PHARM
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
AP05/28/1986N16211000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/019157_PEDIAPRED_ORIGINAL_AP.pdf 4/11/2007
AP08/14/1986SCP       
AP02/2/1989SCS       
AP010/31/1988SCM       
AP010/27/1989SCM       
AP011/8/1993SCS       
AP011/22/1993SLR       
AP05/10/1995SCM       
AP012/17/1998SLR54011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf 12/17/1998
AP012/17/1998SLR57012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf 12/17/1998
AP012/17/1998SLR157013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf 12/17/1998
AP05/29/1997SCS       
AP012/17/1998SE5408015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/19157s11ltr.pdf 12/17/1998
AP01/21/1998SLR6635016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/19-157S016.pdf 9/11/2003
AP01/3/2002SCM       
AP012/3/2004SLR10774018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19157s018ltr.pdf 12/8/2004
AP012/3/2004SLR10775018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19157s018lbl.pdf 12/8/2004
AP012/3/2004SLR14061018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019157_018_PrediapredTOC.cfm 5/8/2006
AP010/8/2013SLR37401020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019157Orig1s020ltr.pdf 10/10/2013
AP010/8/2013SLR37447020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019157s020lbl.pdf 10/17/2013




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