Back to FDA Applications sponsored by BAYER HEALTHCARE LLC

FDA Drug Application 020470 by BAYER HEALTHCARE LLC

Application Number020470
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
AP08/23/1996N       
AP03/26/1997SLR       
AP010/6/1997SLR       
AP01/23/1998SCM15930003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml 3/2/2007
AP05/4/1998SCS       
AP012/4/1998SCS818005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20470-S005_Claritin.pdf 12/4/1998
AP010/29/1998SCM15936007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml 3/2/2007
AP010/1/1999SCS       
AP09/13/2000SCS15940010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/019670_s013,20470s10,18506s018_Claritin-DTOC.cfml 3/2/2007
AP02/14/2000SCS       
AP09/13/2000SCS       
AP01/30/2002SCS       
AP011/27/2002SE62482016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19670se6-018,20470se6-016ltr.pdf 11/27/2002
AP011/27/2002SE610747016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm 12/7/2004
AP012/9/2002SCE       
AP06/25/2003SLR6051019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20470slr019ltr.pdf 7/6/2003
AP07/30/2004SE19925022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19670s019,20470s022ltr.pdf 8/2/2004
AP07/30/2004SE19932022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19670s019,20470s022lbl.pdf 8/2/2004
AP07/15/2004SLR9776023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20470s023ltr.pdf 7/21/2004
AP01/25/2010SLR24801034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019670s22,020470s034ltr.pdf 2/17/2010
AP02/13/2013SCM       
AP04/26/2013SCM       
AP01/3/2014SCM       
AP011/25/2015SLR44617044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019670Orig1s032,020470Orig1s044ltr.pdf 11/27/2015
AP011/25/2015SLR44750044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019670Orig1s032, 020470Orig1s044lbl.pdf 12/11/2015




Back to FDA Applications sponsored by BAYER HEALTHCARE LLC