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FDA Drug Application 020641 by BAYER HEALTHCARE LLC

Application Number020641
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
AP010/10/1996N       
AP01/23/1998SCM15931001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s008,19658s10,20470s3,20641s120704s3_Claritin-DTOC.cfml 3/2/2007
AP03/30/1998SLR       
AP010/29/1998SCM15937003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019670_s012,19658s14,20470s7,20641s3,20704s4_ClaritinDTOC.cfml 3/2/2007
AP01/7/1999SCF       
AP012/4/2000SE52478007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-641S007_Loratadine_Approv.pdf 12/4/2000
AP012/4/2000SE52479007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20641s7lbl.pdf 12/4/2000
AP012/4/2000SE52480007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-641s007_LoratadineClaritin.cfm 12/4/2000
AP011/27/2002SE62477009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19658se6-018,20704se6-008,20641se6-009ltr.pdf 11/27/2002
AP011/27/2002SE610750009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/19670s18,20470s16,19658s18,20704s8,20641s9_Claritin.cfm 12/7/2004
AP07/23/2002SCE       
AP011/19/2003SE66961011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19658se6-020,20704se6-009,20641se6-011ltr.pdf 11/25/2003
AP012/9/2002SCP       
AP07/15/2004SCP9773016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20641s016ltr.pdf 7/21/2004
AP010/27/2004SCS10482017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20641s017ltr.pdf 10/29/2004
AP06/14/2005SCF11818018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020641s018ltr.pdf 6/15/2005
AP07/25/2008SCP20337024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020641s024ltr.pdf 7/30/2008
AP07/25/2008SLR20338025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020641s025ltr.pdf 7/30/2008
AP011/20/2012SCM       
AP02/28/2013SCM35295032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020641Orig1s032ltr.pdf 3/1/2013
AP02/28/2013SCM38266032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020641Orig1s032lbl.pdf 1/14/2014
AP04/16/2013SCM       
AP05/15/2014SCM       
AP04/16/2015SCM42595036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s036lbl.pdf 4/21/2015
AP04/16/2015SCM42614036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s036ltr.pdf 4/22/2015
AP010/21/2015SCM44271037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s037ltr.pdf 10/23/2015
AP010/21/2015SCM44296037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641s037lbl.pdf 10/26/2015
AP011/5/2015SLR44429038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s038ltr.pdf 11/9/2015
AP011/5/2015SLR44598038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s038lbl.pdf 11/25/2015
AP012/10/2015SCM       
AP012/30/2015SLR44920040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020641Orig1s040ltr.pdf 12/31/2015
AP012/30/2015SLR44932040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020641Orig1s040lbl.pdf 1/4/2016
AP02/12/2016SCM       
AP08/9/2016SLR46760042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020641Orig1s042ltr.pdf 8/10/2016
AP08/9/2016SLR46833042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020641Orig1s042lbl.pdf 8/22/2016




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