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FDA Drug Application 203159 by BAYER HLTHCARE

Application Number203159
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/9/2013N34863000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159Orig1s000ltr.pdf 1/11/2013
AP01/9/2013N34873000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s000lbl.pdf 1/11/2013
AP01/9/2013N37343000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203159_skyla_toc.cfm 10/4/2013
AP01/9/2013N37344000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/203159Orig1s000SumR.pdf 10/4/2013
AP08/7/2013SLR36724001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159s001ltredt1.pdf 8/8/2013
AP08/7/2013SLR36764001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s001lbledt1.pdf 8/9/2013
AP09/13/2013SLR37108002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/203159s002lbledt1.pdf 9/17/2013
AP09/13/2013SLR37140002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/203159s002ltredt1.pdf 9/17/2013
AP05/8/2014SCM       
AP04/8/2016SLR45629005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/203159Orig1s005ltr.pdf 4/11/2016
AP04/8/2016SLR45660005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/203159s005lbl.pdf 4/12/2016




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