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FDA Drug Application 022004 by TAKEDA GMBH

Application Number022004
Application Type New Drug Application
Sponsor ApplicantTAKEDA GMBH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/20/2006N15135000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/022004lbl.pdf 10/23/2006
AP010/20/2006N15248000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/022004s000ltr.pdf 10/26/2006
AP010/20/2006N15488000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022004s000TOC.cfm 12/22/2006
AP011/21/2007SLR18586002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/022004s002ltr.pdf 11/26/2007
AP011/21/2007SLR18588002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/022004s002lbl.pdf 11/26/2007
AP05/7/2010SLR25527005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022004s005ltr.pdf 5/12/2010
AP05/7/2010SLR25572005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022004s005lbl.pdf 5/17/2010
AP05/7/2010SLR25528007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022004s007ltr.pdf 5/12/2010
AP03/22/2013SE835512013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022004Orig1s013ltr.pdf 3/26/2013
AP03/22/2013SE835519013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022004s013lbl.pdf 3/26/2013
AP03/17/2016SLR45460015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022004Orig1s015ltr.pdf 3/21/2016
AP06/12/2013SCM       




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