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FDA Drug Application 020667 by BOEHRINGER INGELHEIM

Application Number020667
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
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
AP07/1/1997N111000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667.cfm 7/1/1997
AP07/1/1997N4816000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020667a_appltr.pdf 7/1/1997
AP07/1/1997N33794000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm320049.htm 9/19/2012
AP02/19/1998SLR       
AP02/12/1998SCM       
AP011/26/1997SCM       
AP012/13/1999SCS       
AP011/18/1999SCP       
AP09/3/1999SLR       
AP05/6/2003SLR5767008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20667slr008ltr.pdf 5/30/2003
AP05/6/2003SLR16760008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020667_S008_MirapexTOC.cfm 6/12/2007
AP012/4/2002SCE       
AP011/7/2006SE115331011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf 11/9/2006
AP011/7/2006SE115356011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf 11/14/2006
AP011/7/2006SE115332013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020667s011s013lbl.pdf 11/9/2006
AP011/7/2006SE115355013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020667s011, 020667s013LTR.pdf 11/14/2006
AP012/31/2008SLR21518014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf 1/6/2009
AP012/31/2008SLR21543014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf 1/6/2009
AP012/31/2008SLR21544017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf 1/6/2009
AP012/31/2008SLR21519017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf 1/6/2009
AP012/31/2008SLR21520018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020667s014,020667s017,020667s018ltr.pdf 1/6/2009
AP012/31/2008SLR21545018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020667s014s017s018lbl.pdf 1/6/2009
AP07/17/2012SLR33227019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf 7/18/2012
AP07/17/2012SLR33315019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf 7/30/2012
AP07/17/2012SLR33240021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf 7/19/2012
AP07/17/2012SLR33228021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf 7/18/2012
AP07/17/2012SLR33229022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf 7/18/2012
AP07/17/2012SLR33241022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf 7/19/2012
AP07/17/2012SLR33242023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf 7/19/2012
AP07/17/2012SLR33230023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf 7/18/2012
AP07/17/2012SLR33231024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s019,s021,s022,s023,s024ltr.pdf 7/18/2012
AP07/17/2012SLR33239024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s019s021s022s023s024lbl.pdf 7/19/2012
AP05/13/2011SE828811025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020667s025ltr.pdf 5/16/2011
AP05/13/2011SE828838025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020667s025lbl.pdf 5/16/2011
AP08/31/2012SE833644027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020667Orig1s027ltr.pdf 9/5/2012
AP08/31/2012SE833670027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020667s027lbl.pdf 9/6/2012
AP03/1/2013SLR35324029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020667Orig1s029ltr.pdf 3/4/2013
AP03/1/2013SLR35340029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020667s029lbl.pdf 3/5/2013
AP03/27/2015SLR42325030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf 3/31/2015
AP14/1/2015SLR42325030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf 3/31/2015
AP03/27/2015SLR42383030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf 4/2/2015
AP14/1/2015SLR42383030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbledt.pdf 4/2/2015
AP03/27/2015SLR42390030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbl.pdf 4/2/2015
AP14/1/2015SLR42390030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020667s030lbl.pdf 4/2/2015
AP03/27/2015SLR42415030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf 4/3/2015
AP14/1/2015SLR42415030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020667Orig1s030ltr.pdf 4/3/2015
AP05/11/2015SCM       
AP011/20/2015SCM       
AP01/14/2016SLR44966033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s033ltr.pdf 1/15/2016
AP01/14/2016SLR45014033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s033lbl.pdf 1/25/2016
AP07/28/2016SLR46685034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020667Orig1s034ltr.pdf 8/1/2016
AP07/28/2016SLR46702034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020667s034lbl.pdf 8/2/2016




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