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FDA Drug Application 202100 by NEXTWAVE PHARMS

Application Number202100
Application Type New Drug Application
Sponsor ApplicantNEXTWAVE PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP09/27/2012N33875000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202100lbl.pdf 9/28/2012
AP09/27/2012N33913000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322209.pdf 10/2/2012
AP09/27/2012N33934000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202100Orig1s000ltr.pdf 10/2/2012
AP09/27/2012N36476000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202100_quillivantxr_toc.cfm 7/8/2013
AP09/27/2012N36477000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202100Orig1s000SumR.pdf 7/8/2013
AP09/27/2012N38187000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm283449.htm 12/27/2013
AP05/15/2013SCM36104001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s001lbl.pdf 5/21/2013
AP08/9/2013SLR36769002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202100Orig1s002ltr.pdf 8/12/2013
AP08/9/2013SLR36777002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s002lbl.pdf 8/12/2013
AP012/12/2013SLR38038003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202100Orig1s003ltr.pdf 12/13/2013
AP012/12/2013SLR38052003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202100s003lbl.pdf 12/17/2013
AP04/17/2015SLR42573004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202100Orig1s004ltr.pdf 4/20/2015
AP04/17/2015SLR42610004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100s004lbl.pdf 4/21/2015
AP07/13/2015SLR43370005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/202100Orig1s005ltr.pdf 7/14/2015
AP07/13/2015SLR43439005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/202100Orig1s005lbl.pdf 7/22/2015
AP05/13/2016SLR46028007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/202100Orig1s007ltr.pdf 5/16/2016
AP05/13/2016SLR46041007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/202100s007lbl.pdf 5/17/2016
AP05/27/2016SCM       




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