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FDA Drug Application 020381 by ABBVIE

Application Number020381
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/28/1997N       
AP03/23/1998SCM       
AP03/2/1998SCS       
AP05/12/1998SCM       
AP08/24/1998SCM       
AP010/28/1999SE11170006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381S6LTR.PDF 10/28/1999
AP09/13/1999SE21309007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20381s07ltr.pdf 9/13/1999
AP05/8/2000SCM       
AP06/9/2000SCS       
AP08/2/2000SCS       
AP08/2/2000SCS       
AP011/24/2000SCM       
AP01/31/2003SE14160013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020381s013lbl.pdf 3/5/2003
AP01/31/2003SE19264013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20381se1-013ltr.pdf 6/10/2004
AP09/5/2002SCS       
AP06/8/2005SLR11787020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s020ltr.pdf 6/10/2005
AP06/8/2005SLR11788020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s020lbl.pdf 6/10/2005
AP09/9/2005SCF12781023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020381s023ltr.pdf 9/15/2005
AP09/9/2005SCF12802023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020381s023lbl.pdf 9/15/2005
AP04/11/2006SLR13893025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020381s025lbl.pdf 4/12/2006
AP04/11/2006SLR13902025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020381s025ltr.pdf 4/12/2006
AP04/4/2007SCS16168027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s027ltr.pdf 4/9/2007
AP05/29/2008SLR19905032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020632s030, 020381s032ltr.pdf 5/30/2008
AP012/18/2007SLR18685034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020381s034lbl.pdf 12/27/2007
AP012/18/2007SLR18833034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020381s034ltr.pdf 1/9/2008
AP03/26/2009SLR22141038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s038ltr.pdf 4/1/2009
AP09/16/2009SLR23428039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf 9/21/2009
AP09/16/2009SLR23836039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf 11/12/2009
AP09/16/2009SLR23429041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020381s039s041lbl.pdf 9/21/2009
AP09/16/2009SLR23837041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020381s039s041ltr.pdf 11/12/2009
AP02/24/2010SLR24915042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s042ltr.pdf 3/3/2010
AP02/24/2010SLR24927042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s042lbl.pdf 3/3/2010
AP011/9/2010SLR26929043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020381s043ltr.pdf 11/12/2010
AP011/9/2010SLR26944043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020381s043lbl.pdf 11/12/2010
AP02/21/2013SLR35225048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020381Orig1s048,022078Orig1s015ltr.pdf 2/25/2013
AP02/21/2013SLR35257048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020381s048lbl.pdf 2/26/2013
AP06/18/2013SCM       
AP05/27/2015SCM       
AP04/27/2015SLR42662051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020381Orig1s051lbl.pdf 4/27/2015
AP04/27/2015SLR42669051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020381Orig1s051ltr.pdf 4/28/2015
AP010/28/2015SCM       




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