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FDA Drug Application 021303 by SHIRE

Application Number021303
Application Type New Drug Application
Sponsor ApplicantSHIRE
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
AP010/11/2001N2633000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall_Approv.pdf 10/11/2001
AP010/11/2001N2634000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21303lbl.pdf 10/11/2001
AP010/11/2001N8582000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21303_Adderall.cfm 5/25/2004
AP010/11/2001N11409000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111441.htm 4/15/2005
AP010/11/2001N24213000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085819.pdf 12/4/2009
AP05/22/2002SCM2631001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21303s001ltr.pdf 5/22/2002
AP05/22/2002SCM2632001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21303s1lbl.pdf 5/22/2002
AP05/22/2002SCM16824001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021303_S001_AdderallTOC.cfm 6/22/2007
AP09/13/2002SCS       
AP08/11/2004SE510004005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21303s005ltr.pdf 8/12/2004
AP08/11/2004SE511086005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021303s005lbl.pdf 2/7/2005
AP07/21/2005SE512271009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021303s009ltr.pdf 7/26/2005
AP07/21/2005SE512285009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021303s009lbl.pdf 7/26/2005
AP06/16/2006SLR14324010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021303s010lbl.pdf 6/20/2006
AP06/16/2006SLR14332010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021303s010LTR.pdf 6/20/2006
AP07/26/2006SLR14538013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/011522s034s037,021303s013lbl.pdf 7/27/2006
AP07/26/2006SLR14550013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/011522s034, 037, 021303s013LTR.pdf 7/27/2006
AP05/22/2007SLR16598015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021303s015ltr.pdf 5/29/2007
AP05/22/2007SLR16643015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021303s015lbl.pdf 5/29/2007
AP011/12/2008SLR21224019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021303s019,021977s008ltr.pdf 11/13/2008
AP011/12/2010SLR26961020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022lbl.pdf 11/17/2010
AP011/12/2010SLR26962020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022MedGuide.pdf 11/17/2010
AP011/12/2010SLR26976020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021303s020,s022ltr.pdf 11/18/2010
AP011/12/2010SLR26959022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022MedGuide.pdf 11/17/2010
AP011/12/2010SLR26960022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021303s020s022lbl.pdf 11/17/2010
AP011/12/2010SLR26977022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021303s020,s022ltr.pdf 11/18/2010
AP02/7/2012SLR31723023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021303s023mg.pdf 2/9/2012
AP02/7/2012SLR31724023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021303s023lbl.pdf 2/9/2012
AP02/7/2012SLR31735023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021303s023ltr.pdf 2/10/2012
AP06/14/2013SLR36299024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s024lbl.pdf 6/18/2013
AP06/14/2013SLR36329024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s024ltr.pdf 6/18/2013
AP03/8/2013SLR35396025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s025ltr.pdf 3/11/2013
AP03/8/2013SLR35430025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s025lbl.pdf 3/12/2013
AP012/3/2013SLR37962026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021303s026lbl.pdf 12/4/2013
AP012/3/2013SLR37975026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021303Orig1s026ltr.pdf 12/5/2013
AP07/24/2014SLR40003027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021303Orig1s027ltr.pdf 7/25/2014
AP07/24/2014SLR40011027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021303s027lbl.pdf 7/28/2014
AP03/3/2015SCM       
AP04/17/2015SLR42586031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021303Orig1s031ltr.pdf 4/21/2015
AP04/17/2015SLR42602031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021303s031lbl.pdf 4/21/2015




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