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FDA Drug Application 021782 by TAKEDA PHARMS USA

Application Number021782
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
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
AP07/22/2005N12272000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021782ltr.pdf 7/26/2005
AP07/22/2005N12286000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021782lbl.pdf 7/26/2005
AP07/22/2005N12666000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109091.htm 8/30/2005
AP07/22/2005N12949000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021782s000_RozeremTOC.cfm 10/20/2005
AP07/22/2005N24074000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM143463.pdf 11/20/2009
AP08/18/2005SLR12652001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021782s001ltr.pdf 8/23/2005
AP08/18/2005SLR12657001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021782s001lbl.pdf 8/23/2005
AP03/1/2012SLR32023006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021782s006,s012,s014ltr.pdf 3/5/2012
AP010/20/2008SE821069008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021782s008, s009, s010ltr.pdf 10/23/2008
AP010/20/2008SE821182008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf 11/7/2008
AP010/20/2008SE821183009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf 11/7/2008
AP010/20/2008SE821070009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021782s008, s009, s010ltr.pdf 10/23/2008
AP010/20/2008SE821071010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021782s008, s009, s010ltr.pdf 10/23/2008
AP010/20/2008SE821184010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021782s008s009s010lbl.pdf 11/7/2008
AP011/9/2010SLR26942011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021782s011Medguide.pdf 11/12/2010
AP011/9/2010SLR26943011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021782s011lbl.pdf 11/12/2010
AP011/9/2010SLR26952011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021782s011ltr.pdf 11/15/2010
AP02/21/2012SLR32024012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021782s006,s012,s014ltr.pdf 3/5/2012
AP03/1/2012SLR32025014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021782s006,s012,s014ltr.pdf 3/5/2012
AP08/4/2011SLR29697015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021782s015ltr.pdf 8/5/2011
AP06/14/2013SCM       
AP07/13/2016SCM       
AP04/6/2016SCM       




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