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FDA Drug Application 018828 by DELCOR ASSET CORP

Application Number018828
Application Type New Drug Application
Sponsor ApplicantDELCOR ASSET CORP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/25/1985N       
AP012/22/1989SE1       
AP012/2/1986SLR       
AP010/29/1987SLR       
AP04/22/1993SLR       
AP010/24/1988SCS       
AP04/20/1990SE1       
AP010/24/1988SLR       
AP04/30/1991SLR       
AP02/26/1992SE13714010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18828S010_Zovirax.pdf 7/5/2000
AP04/22/1993SLR       
AP011/9/1993SCS       
AP04/14/1994SLR       
AP04/12/1995SLR       
AP010/29/1996SCS       
AP01/8/1997SLR       
AP05/29/1997SLR       
AP011/4/1997SCM       
AP03/15/2000SLR       
AP02/18/1999SCP       
AP03/15/2000SLR       
AP07/12/2000SCM       
AP011/14/2001SLR5258026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf 4/15/2003
AP011/14/2001SLR5259027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18828s26s27lbl.pdf 4/15/2003
AP05/19/2004SLR8671029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/18828slr029,19909slr019,20089slr018ltr.pdf 5/27/2004
AP05/19/2004SLR8687029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18828slr029,19909slr019,20089slr018_zovirax_lbl.pdf 5/27/2004
AP012/9/2005SLR13255030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018828s030,020089s019,019909s020lbl.pdf 12/15/2005
AP012/9/2005SLR13265030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018828s030,020089s019,019909s020ltr.pdf 12/15/2005
AP08/8/2008SLR20601031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020089s020, 019909s022, 018828s031ltr.pdf 8/13/2008
AP08/8/2008SLR45548031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/018828s031lbl.pdf 3/30/2016




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