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FDA Drug Application 019909 by DELCOR ASSET

Application Number019909
Application Type New Drug Application
Sponsor ApplicantDELCOR ASSET
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
AP012/22/1989N       
AP04/26/1990SLR       
AP04/30/1991SLR       
AP02/26/1992SE13715003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19909S003_Zovirax.pdf 7/6/2000
AP04/22/1993SLR       
AP011/9/1993SCS       
AP04/14/1994SLR       
AP04/12/1995SLR       
AP010/29/1996SCS       
AP01/8/1997SLR       
AP05/29/1997SLR       
AP02/25/1998SCM       
AP03/15/2000SLR       
AP07/12/2000SCM       
AP011/14/2001SLR5905016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19909s16s17lbl.pdf 6/10/2003
AP011/14/2001SLR5906017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19909s16s17lbl.pdf 6/10/2003
AP05/19/2004SLR8672019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18828slr029,19909slr019,20089slr018ltr.pdf 5/27/2004
AP05/19/2004SLR8689019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf 5/27/2004
AP012/9/2005SLR13253020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf 12/15/2005
AP012/9/2005SLR13263020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018828s030,020089s019,019909s020ltr.pdf 12/15/2005
AP08/8/2008SLR20600022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020089s020, 019909s022, 018828s031ltr.pdf 8/13/2008
AP04/18/2016SCM       




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