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FDA Drug Application 202129 by TAKEDA GMBH

Application Number202129
Application Type New Drug Application
Sponsor ApplicantTAKEDA GMBH
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
AP01/20/2012N31503000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202129s000lbl.pdf 1/24/2012
AP01/20/2012N31509000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202129s000ltr.pdf 1/25/2012
AP01/20/2012N34260000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202129_zetonna_toc.cfm 11/5/2012
AP01/20/2012N34261000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202129Orig1s000SumR.pdf 11/5/2012
AP012/20/2012SCM       
AP01/31/2014SCM       
AP04/22/2014SCM       
AP010/23/2014SE840882004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf 10/27/2014
AP010/23/2014SE841015004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf 11/18/2014
AP010/23/2014SE840883005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf 10/27/2014
AP010/23/2014SE841016005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf 11/18/2014
AP010/23/2014SE840884006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202129Orig1s004,s005,s006ltr.pdf 10/27/2014
AP010/23/2014SE841017006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202129s004s005s006lbl.pdf 11/18/2014




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