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FDA Drug Application 020629 by DENCO ASSET

Application Number020629
Application Type New Drug Application
Sponsor ApplicantDENCO ASSET
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/24/1996N       
AP09/22/1998SCS       
AP012/22/1998SCM       
AP08/18/2001SCS       
AP010/10/2003SE56801008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20629se5-008ltr.pdf 10/16/2003
AP010/10/2003SE56802008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20629se5-008_denavir_lbl.pdf 10/16/2003
AP04/17/2003SLR5362009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20629slr009_denavir_lbl.pdf 4/17/2003
AP04/17/2003SLR5379009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20629slr009ltr.pdf 4/18/2003
AP09/11/2013SLR37082016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020629Orig1s016ltr.pdf 9/13/2013
AP09/11/2013SLR37118016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020629s016lbl.pdf 9/17/2013
AP02/9/2015SCM       




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