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FDA Drug Application 020704 by BAYER HEALTHCARE LLC

Application Number020704
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
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
AP012/23/1996N       
AP05/29/1998SCP       
AP09/19/1997SCS       
AP01/23/1998SCM15932003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml 3/2/2007
AP010/29/1998SCM15938004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml 3/2/2007
AP09/18/2000SCS       
AP011/27/2002SE62476008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19658se6-018,20704se6-008,20641se6-009ltr.pdf 11/27/2002
AP011/27/2002SE610749008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm 12/7/2004
AP011/19/2003SE66960009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-020,20704se6-009,20641se6-011ltr.pdf 11/25/2003
AP01/19/2006SCP13541014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020704s014ltr.pdf 1/30/2006
AP010/21/2008SLR21051020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020704s020ltr.pdf 10/23/2008
AP01/29/2009SCM21703021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020704s021ltr.pdf 2/3/2009
AP07/22/2014SLR39960027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020704Orig1s027,021993Orig1s012ltr.pdf 7/24/2014
AP07/22/2014SLR40053027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020704Orig1s027, 021993Orig1s012lbl.pdf 7/29/2014
AP011/25/2015SLR44614028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021993Orig1s013,020704Orig1s028ltr.pdf 11/27/2015
AP011/25/2015SLR44642028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021993Orig1s013, 020704Orig1s028lbl.pdf 12/1/2015




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