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FDA Drug Application 019658 by BAYER HEALTHCARE LLC

Application Number019658
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/12/1993N       
AP09/12/1996SLR       
AP09/17/1993SLR       
AP09/20/1995SE1       
AP02/9/1995SCM       
AP010/12/1995SLR3728005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19658-S005_Claritin.pdf 5/25/2001
AP09/1/1995SCS       
AP07/14/1997SLR       
AP01/27/1998SLR       
AP01/23/1998SCM15929010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml 3/2/2007
AP05/8/1998SCS       
AP01/27/1999SCM       
AP010/29/1998SCM15935014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml 3/2/2007
AP07/23/1999SCS       
AP011/27/2002SE62475018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19658se6-018,20704se6-008,20641se6-009ltr.pdf 11/27/2002
AP011/27/2002SE610748018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm 12/7/2004
AP012/10/2002SCM       
AP011/19/2003SE66959020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-020,20704se6-009,20641se6-011ltr.pdf 11/25/2003
AP06/25/2003SLR6041021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658slr021ltr.pdf 7/6/2003
AP012/20/2007SLR18790026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019658s026_rc.pdf 1/9/2008
AP012/20/2007SLR37152026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019658s026lbl.pdf 9/18/2013
AP011/16/2012SCM       
AP06/5/2013SCM       
AP09/14/2015SCM       
AP012/18/2015SLR44835044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019658Orig1s044ltr.pdf 12/22/2015
AP012/18/2015SLR44857044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019658Orig1s044lbl.pdf 12/22/2015
AP08/9/2016SLR46759045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019658Orig1s045ltr.pdf 8/10/2016
AP08/9/2016SLR46834045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019658Orig1s045lbl.pdf 8/22/2016




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