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FDA Drug Application 022281 by BAYER HEALTHCARE LLC

Application Number022281
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
AP012/1/2009N24180000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022281s000ltr.pdf 12/2/2009
AP012/1/2009N24191000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022281lbl.pdf 12/4/2009
AP012/1/2009N24828000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022281s000TOC.cfm 2/23/2010
AP012/1/2009N31066000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP04/15/2010SLR25370001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s001ltr.pdf 4/28/2010
AP012/20/2010SLR27324002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s002ltr.pdf 12/22/2010
AP012/20/2010SLR27325003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022281s003ltr.pdf 12/22/2010
AP07/25/2011SLR29629005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022281s005ltr.pdf 7/28/2011
AP07/25/2011SLR32237005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022281Orig1s005lbl.pdf 3/27/2012
AP09/18/2012SLR33820006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022281Orig1s006ltr.pdf 9/24/2012
AP09/18/2012SLR38282006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022281Orig1s006lbl.pdf 1/15/2014
AP011/15/2013SCM       
AP06/10/2015SLR43040008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022281Orig1s008ltr.pdf 6/11/2015
AP06/10/2015SLR43313008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022281s008lbl.pdf 7/10/2015
AP04/21/2016SCM       




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