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FDA Drug Application 022015 by BAYER HEALTHCARE LLC

Application Number022015
Application Type New Drug Application
Sponsor ApplicantBAYER HEALTHCARE LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type OTC (over-the-counter) switch
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/6/2006N15089000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022015s000ltr.pdf 10/13/2006
AP010/6/2006N16813000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_TOC.cfm 6/22/2007
AP011/20/2008SCP21259002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022015s002ltr.pdf 11/21/2008
AP012/2/2008SCP21321003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022015s003ltr.pdf 12/4/2008
AP05/5/2010SLR25481006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022015s006ltr.pdf 5/7/2010
AP03/15/2012SLR32150012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022015Orig1s012ltr.pdf 3/19/2012
AP01/4/2013SCM       
AP010/22/2013SCM       
AP09/24/2015SCM       
AP03/5/2014SCM       
AP08/3/2014SCM40125020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022015Orig1s020lbl.pdf 8/4/2014
AP08/3/2014SCM40161020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022015Orig1s020ltr.pdf 8/6/2014
AP07/14/2015SCM       
AP010/29/2015SLR44352023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022015Orig1s023ltr.pdf 11/4/2015
AP010/29/2015SLR44383023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022015Orig1s023lbl.pdf 11/4/2015
AP011/12/2015SLR44476024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022015Orig1s024ltr.pdf 11/16/2015
AP011/12/2015SLR44545024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022015Orig1s024lbl.pdf 11/19/2015
AP09/30/2016SLR47279025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022015Orig1s025ltr.pdf 10/5/2016
AP09/30/2016SLR47316025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022015Orig1s025lbl.pdf 10/11/2016
AP010/21/2016SLR47434026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022015Orig1s026ltr.pdf 10/25/2016
AP010/21/2016SLR47478026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022015Orig1s026lbl.pdf 10/27/2016




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