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FDA Drug Application 125388 by SEATTLE GENETICS

Application Number125388
Application Type Biologic License Application
Sponsor ApplicantSEATTLE GENETICS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/19/2011N29827000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/125388s000,125399s000lbl.pdf 8/19/2011
AP08/19/2011N29828000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/125388s000,125399s000ltr.pdf 8/19/2011
AP08/19/2011N30187000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388_adcetris_toc.cfm 10/3/2011
AP08/19/2011N30190000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/125388Orig1s000SumR.pdf 10/3/2011
AP08/19/2011N31748000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm287672.htm 2/13/2012
AP01/13/2012S31387005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/125388s0005lbl.pdf 1/13/2012
AP01/13/2012S31415005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/125388s005ltr.pdf 1/19/2012
AP08/19/2013S36863045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/125388s045lbl.pdf 8/21/2013
AP08/19/2013S36866045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/125388Orig1s045ltr.pdf 8/22/2013
AP011/21/2014S41088056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf 11/25/2014
AP011/21/2014S41097056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf 11/26/2014
AP011/21/2014S41087078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/125388_S056S078lbl.pdf 11/25/2014
AP011/21/2014S41098078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/125388Orig1s056,s078ltr.pdf 11/26/2014
AP08/17/2015S43660080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf 8/17/2015
AP08/17/2015S43661080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf 8/17/2015
AP08/17/2015S43662081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125388Orig1s080s081Ltr.pdf 8/17/2015
AP08/17/2015S43663081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125388s080lbl.pdf 8/17/2015
AP03/4/2016SLR45391084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s084ltr.pdf 3/8/2016
AP03/4/2016SLR45396084   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s084lbl.pdf 3/8/2016
AP09/28/2016SLR47219088   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125388s088lbl.pdf 9/29/2016
AP09/28/2016SLR47243088   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125388Orig1s088ltr.pdf 9/30/2016




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