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FDA Drug Application 019670 by BAYER HEALTHCARE LLC

Application Number019670
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/14/1994N       
AP02/7/1997SCS       
AP09/22/1995SCS       
AP04/29/1996SLR       
AP02/5/1997SLR       
AP07/21/1997SCS       
AP07/14/1997SLR       
AP05/4/1998SCS       
AP01/23/1998SCM15928008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml 3/2/2007
AP01/27/1999SCS15933009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1999/019670_s009_Claritin-DTOC.cfml 3/2/2007
AP04/29/1998SLR       
AP010/29/1998SCM15934012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml 3/2/2007
AP09/13/2000SCS15939013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml 3/2/2007
AP03/22/2000SCS15942014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s014_Claritin-DTOC.cfml 3/2/2007
AP011/1/2000SCS15943015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s015,018506s022_Claritin-DTOC.cfml 3/2/2007
AP03/4/2002SCE15945017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019670_S017_Claritin-DTOC.cfml 3/2/2007
AP011/27/2002SE62481018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19670se6-018,20470se6-016ltr.pdf 11/27/2002
AP011/27/2002SE610742018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm 12/7/2004
AP07/30/2004SE19924019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19670s019,20470s022ltr.pdf 8/2/2004
AP07/30/2004SE19931019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf 8/2/2004
AP04/23/2009SCF31016020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/019670Orig1s020.pdf 12/16/2011
AP04/23/2009SCF22328020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019670s020ltr.pdf 4/27/2009
AP01/25/2010SLR24800022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034ltr.pdf 2/17/2010
AP03/13/2013SCM       
AP010/18/2013SCM       
AP011/25/2015SLR44616032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470Orig1s044ltr.pdf 11/27/2015
AP011/25/2015SLR44749032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf 12/11/2015




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