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FDA Drug Application 021428 by TAKEDA PHARMS USA

Application Number021428
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS USA
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
AP08/30/2002N3694000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf 8/30/2002
AP08/30/2002N3695000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf 8/30/2002
AP08/30/2002N11855000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.cfm 6/23/2005
AP08/30/2002N31070000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP08/30/2002N33938000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322354.pdf 10/3/2012
AP08/5/2003SLR6518001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf 8/15/2003
AP06/15/2004SLR       
AP06/17/2004SE89498004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf 6/23/2004
AP06/17/2004SE89503004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf 12/21/2004
AP06/17/2004SE820356004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021428_S004_PREVACID DELAYED RELEASE CAPS.pdf 7/31/2008
AP04/12/2006SLR13924006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf 4/13/2006
AP04/12/2006SLR13930006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf 4/13/2006
AP06/14/2007SLR16828012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf 6/27/2007
AP06/14/2007SLR16923012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf 7/5/2007
AP04/21/2008SLR19705013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf 4/23/2008
AP010/28/2008SE521104017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf 10/29/2008
AP010/28/2008SE521155017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf 11/7/2008
AP07/31/2009S23173019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf 8/13/2009
AP07/31/2009S23835019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf 11/12/2009
AP05/12/2010SLR25551020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s073,021428s020ltr.pdf 5/17/2010
AP05/12/2010SLR25568020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s073,021428s020lbl.pdf 5/17/2010
AP09/3/2010SLR26453021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf 9/10/2010
AP06/1/2011SLR29024022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s075,021428s022ltr.pdf 6/3/2011
AP06/1/2011SLR29032022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s075,021428s022lbl.pdf 6/7/2011
AP010/28/2011SLR30439023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s076,021428s023ltr.pdf 10/31/2011
AP010/28/2011SLR30448023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf 11/1/2011
AP05/20/2011SLR28942024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s077,021428s024ltr.pdf 5/25/2011
AP05/20/2011SLR28965024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s077,021428s024lbl.pdf 5/26/2011
AP09/28/2012SLR33886025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf 10/1/2012
AP09/28/2012SLR33900025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406Orig1s078,021428Orig1s025ltr.pdf 10/2/2012
AP05/3/2012SLR32636026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.pdf 5/7/2012
AP05/3/2012SLR32666026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406s079,021428s026ltr.pdf 5/9/2012
AP012/16/2015SLR44812027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020406s080-021428s027lbl.pdf 12/17/2015
AP012/16/2015SLR44819027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020406Orig1s080;021428Orig1s027ltr.pdf 12/18/2015
AP012/19/2014SLR41382028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020406Orig1s081,021428Orig1s028ltr.pdf 12/24/2014
AP012/19/2014SLR41427028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf 12/29/2014
AP09/21/2016SCM       
AP010/24/2016SLR47460030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021428Orig1s030,020406Orig1s082ltr.pdf 10/26/2016
AP010/24/2016SLR47534030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020406s082,021428s030lbl.pdf 10/31/2016




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