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FDA Drug Application 021676 by BAYER HLTHCARE

Application Number021676
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/16/2006N13786000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021676s000lbl.pdf 3/22/2006
AP03/16/2006N13794000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021676s000ltr.pdf 3/23/2006
AP03/16/2006N17500000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021676s000TOC.cfm 8/6/2007
AP03/16/2006N30585000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm257168.htm 11/16/2011
AP01/26/2007SLR15752002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021676s002ltr.pdf 2/2/2007
AP03/11/2011SE128239008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021676s008lbl.pdf 3/14/2011
AP03/11/2011SE128259008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021676s008ltr.pdf 3/16/2011
AP04/7/2010SLR25251009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021676s009ltr.pdf 4/12/2010
AP04/7/2010SLR25268009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021676s009lbl.pdf 4/16/2010
AP04/10/2012SLR32387012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021676s012lbl.pdf 4/10/2012
AP04/10/2012SLR32405012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf 4/12/2012
AP04/10/2012SLR45098012   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/021676Orig1s012.pdf 2/3/2016
AP01/31/2013SCM       
AP06/1/2015SLR42973014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf 6/3/2015
AP06/1/2015SLR42991014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021676s014lbl.pdf 6/4/2015
AP03/4/2016SCM       
AP09/30/2014SCM       
AP07/31/2015SCM       




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