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FDA Drug Application 020478 by ABBVIE

Application Number020478
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 Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/7/1995N       
AP07/2/1997SCP       
AP012/23/1997SLR       
AP08/6/1998SLR       
AP06/16/2000SCP       
AP03/30/2001SE81616006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20478S6LTR.PDF 3/30/2001
AP03/30/2001SE81617006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20478S6LBL.PDF 3/30/2001
AP03/30/2001SE816656006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020478_S006_ULTANE_AP.pdf 5/29/2007
AP012/11/2002SLR9601007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20478slr007ltr.pdf 6/29/2004
AP012/11/2002SLR16658007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020478s007TOC.cfm 5/30/2007
AP03/14/2001SCS       
AP09/28/2001SCS       
AP08/9/2001SLR       
AP05/24/2002SCM       
AP06/27/2003SLR6052012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20478slr012ltr.pdf 7/6/2003
AP06/21/2005SLR11871013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020478s013ltr.pdf 6/23/2005
AP06/21/2005SLR11876013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020478s013lbl.pdf 6/23/2005
AP06/27/2006SLR14376016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020478s016lbl.pdf 6/28/2006
AP06/27/2006SLR14411016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020478s016ltr.pdf 7/3/2006
AP01/21/2010SLR24597018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020478s018lbl.pdf 1/24/2010
AP01/21/2010SLR24656018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020478s018ltr.pdf 1/28/2010
AP08/16/2012SLR33499019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020478Orig1s019,s020ltr.pdf 8/17/2012
AP08/16/2012SLR33511019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf 8/17/2012
AP08/16/2012SLR33500020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020478Orig1s019,s020ltr.pdf 8/17/2012
AP08/16/2012SLR33512020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020478s019s020lbl.pdf 8/17/2012
AP03/11/2014SLR38773025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020478Orig1s025,s026ltr.pdf 3/13/2014
AP03/11/2014SLR38790025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf 3/13/2014
AP03/11/2014SLR38774026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020478Orig1s025,s026ltr.pdf 3/13/2014
AP03/11/2014SLR38791026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020478s025s026lbl.pdf 3/13/2014
AP010/26/2015SCM       




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