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FDA Drug Application 018647 by KING PHARMS

Application Number018647
Application Type New Drug Application
Sponsor ApplicantKING PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/25/1983N30534000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/18-647_corzide.pdf 11/8/2011
AP03/6/1984SCP       
AP03/6/1984SCP       
AP04/25/1985SCP       
AP010/22/1985SLR       
AP01/6/1987SCP       
AP03/22/1989SCE       
AP03/4/1993SCM       
AP08/9/1990SLR       
AP012/5/1990SLR       
AP03/28/1991SCM       
AP03/20/1992SCM       
AP03/18/1996SCS       
AP08/11/1997SCM       
AP05/6/1998SCM       
AP05/7/2002SCM       
AP05/30/2003SLR5792016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18647slr016ltr.pdf 6/8/2003
AP08/6/2008SLR20512020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/018647s020ltr.pdf 8/7/2008
AP06/6/2011SLR29080024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018647s024ltr.pdf 6/9/2011
AP06/6/2011SLR29287024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018647s024lbl.pdf 6/27/2011
AP07/15/2013SLR36561025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/018647s025lbl.pdf 7/15/2013
AP07/15/2013SLR36564025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/018647Orig1s025ltr.pdf 7/16/2013




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