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FDA Drug Application 202429 by HOFFMANN LA ROCHE

Application Number202429
Application Type New Drug Application
Sponsor ApplicantHOFFMANN LA ROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/17/2011N29815000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429s000lbl.pdf 8/17/2011
AP08/17/2011N29816000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM268332.pdf 8/17/2011
AP08/17/2011N29817000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202429Orig1s000ltr.pdf 8/17/2011
AP08/17/2011N29818000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202429Orig1s000SumR.pdf 8/17/2011
AP08/17/2011N30386000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202429s000TOC.cfm 10/21/2011
AP08/17/2011N36609000Medication Guide  http://www.fda.gov/downloads/Drugs/DrugSafety/UCM268332.pdf 7/26/2013
AP07/3/2013SLR36453002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003ltr.pdf 7/5/2013
AP07/3/2013SLR36465002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf 7/5/2013
AP07/3/2013SLR36454003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202429Orig1s002,s003ltr.pdf 7/5/2013
AP07/3/2013SLR36466003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202429s002s003lbl.pdf 7/5/2013
AP03/19/2014SE838854004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s004ltr.pdf 3/20/2014
AP03/19/2014SE838856004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s004lbl.pdf 3/20/2014
AP02/6/2014SLR38477005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s005lbl.pdf 2/7/2014
AP02/6/2014SLR38493005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s005ltr.pdf 2/11/2014
AP011/25/2014SLR41103006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202429Orig1s006ltr.pdf 11/28/2014
AP011/25/2014SLR41140006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202429s006lbl.pdf 12/3/2014
AP09/23/2014SCM       
AP08/11/2015SLR43630008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202429Orig1s008ltr.pdf 8/12/2015
AP08/11/2015SLR43634008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202429s008lbl.pdf 8/12/2015
AP08/31/2016SE846936009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s009lbl.pdf 9/1/2016
AP08/31/2016SE846948009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202429Orig1s009ltr.pdf 9/2/2016
AP05/9/2016SLR45908010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202429Orig1s010ltr.pdf 5/11/2016
AP05/9/2016SLR45993010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202429s010lbl.pdf 5/11/2016




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