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FDA Drug Application 205352 by BAYER HLTHCARE

Application Number205352
Application Type New Drug Application
Sponsor ApplicantBAYER HLTHCARE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/16/2014N38314000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s000ltr_corrected.pdf 1/17/2014
AP01/16/2014N38395000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s000lbl_corrected.pdf 1/28/2014
AP01/16/2014N42818000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205352Orig1s000TOC.cfm 5/14/2015
AP01/16/2014N42819000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/205352Orig1s000SumR.pdf 5/14/2015
AP08/28/2014SLR40360001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s001ltr.pdf 9/3/2014
AP08/28/2014SLR40575001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s001lbl.pdf 9/23/2014
AP011/20/2014SLR41068002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205352Orig1s002ltr.pdf 11/24/2014
AP011/20/2014SLR41532002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205352Orig1s002lbl.pdf 1/8/2015
AP02/25/2015SLR41940003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s003ltr.pdf 2/27/2015
AP02/25/2015SLR42133003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s003lbl.pdf 3/12/2015
AP07/15/2015SLR43394004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s004ltr.pdf 7/16/2015
AP07/15/2015SLR43442004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s004lbl.pdf 7/22/2015
AP08/14/2015SLR43667005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s005ltr.pdf 8/18/2015
AP08/14/2015SLR43725005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s005lbl.pdf 8/26/2015
AP010/28/2015SLR44332006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205352Orig1s006lbl.pdf 10/29/2015
AP010/28/2015SLR44337006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s006ltr.pdf 10/30/2015
AP012/23/2015SCM44910007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205352Orig1s007ltr.pdf 12/30/2015
AP08/16/2016SCM       




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