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FDA Drug Application 020098 by ABBVIE

Application Number020098
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/22/1992N       
AP02/8/1995SLR       
AP03/2/1994SLR       
AP04/15/1994SCS       
AP01/25/1994SLR       
AP08/18/1994SCS       
AP06/9/1995SCM       
AP06/4/1997SCS       
AP05/19/1998SLR443009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron.cfm 7/3/2000
AP05/19/1998SLR9232009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron_appltr_prntlbl.pdf 6/9/2004
AP05/19/1998SLR9233009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20098S009_Mivacron_appltr_prntlbl.pdf 6/9/2004
AP06/25/1999SLR       
AP03/17/1999SCM       
AP02/20/2001SLR       
AP06/4/2002SCM3620013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20098s013ltr.pdf 6/4/2002
AP010/15/2002SCM       
AP011/22/2010SLR27087017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020098s017ltr.pdf 11/30/2010
AP011/22/2010SLR27105017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020098s017lbl.pdf 11/22/2010
AP01/30/2015SCM41773018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020098s018lbl.pdf 2/3/2015




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