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FDA Drug Application 020712 by SHIRE

Application Number020712
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
AP09/30/1997N16228000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020712_carbatrol_toc.cfm 4/17/2007
AP07/24/1998SCS       
AP01/27/1999SCS       
AP01/27/1999SCM       
AP06/28/1999SCP       
AP06/28/1999SCP       
AP012/22/1999SCM       
AP011/8/1999SCP       
AP01/19/2000SCS       
AP06/14/2000SCM       
AP05/17/2001SCS       
AP08/8/2000SCM       
AP08/8/2000SCM       
AP010/30/2001SCM       
AP02/21/2002SCM       
AP08/7/2002SCM       
AP01/24/2006SLR13542024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s024ltr.pdf 1/30/2006
AP06/30/2006SLR14397025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020712s025lbl.pdf 7/3/2006
AP06/30/2006SLR14468025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020712s025LTR.pdf 7/13/2006
AP012/11/2007SLR18640029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020712s029lbl.pdf 12/12/2007
AP012/11/2007SLR18694029Clinical Review  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/016608s098,020712s029,021710_ClinRev.pdf 12/31/2007
AP012/11/2007SLR18849029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020712s029ltr.pdf 1/9/2008
AP04/23/2009SLR22342030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020712s030lbl.pdf 4/28/2009
AP04/23/2009SLR22358030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020712s030ltr.pdf 4/29/2009
AP01/26/2011SLR27642031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020712s031MedG.pdf 1/31/2011
AP01/26/2011SLR27643031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020712s031lbl.pdf 1/31/2011
AP01/26/2011SLR27679031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s031ltr.pdf 2/3/2011
AP03/22/2013SLR35507032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035ltr.pdf 3/25/2013
AP03/22/2013SLR35517032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf 3/26/2013
AP03/22/2013SLR36121032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf 5/22/2013
AP08/22/2011SLR29954034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020712s034ltr.pdf 9/6/2011
AP03/22/2013SLR35506035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020712Orig1s032,s035ltr.pdf 3/25/2013
AP03/22/2013SLR35518035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035lbl.pdf 3/26/2013
AP03/22/2013SLR36122035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020712s032s035mg.pdf 5/22/2013




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