Back to FDA Applications sponsored by TAKEDA PHARMS USA

FDA Drug Application 020406 by TAKEDA PHARMS USA

Application Number020406
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
AP05/10/1995N25040000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_prevacid_toc.cfm 3/16/2010
AP05/10/1995N31068000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP05/10/1995N33937000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM322354.pdf 10/3/2012
AP05/10/1995N45704000   http://www.accessdata.fda.gov/drugsatfda_docs/label/pre96/020406Orig1s000lbl.pdf 4/20/2016
AP011/30/1995SLR       
AP04/8/1996SE1       
AP010/18/1995SLR23341004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s004_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP05/6/1996SCP23342005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s005_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP01/30/1996SLR23343006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s006_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP07/25/1996SCP23344007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020406_s007_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP09/13/1996SCP       
AP02/25/1997SLR23345009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s009_PrevacidDelayedReleaseCaps.pdf 9/16/2009
AP04/17/1997SE1       
AP05/8/1997SE1       
AP012/24/1996SLR       
AP06/17/1997SLR       
AP06/17/1997SLR       
AP03/12/1998SE1297016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20406S016.cfm 3/12/1998
AP09/17/1997SCM30918017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406Orig1s017.pdf 12/9/2011
AP06/23/1997SLR23346018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s018_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP09/17/1997SCM23347019   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s019_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP09/4/1997SCM23348020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020406_s020_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP07/20/1998SE2476021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20406S021ltr.pdf 7/20/1998
AP07/20/1998SE2477021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20406-s021.cfm 7/20/1998
AP07/20/1998SLR605022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20406S021ltr.pdf 7/20/1998
AP07/20/1998SLR606022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_S022_PREVACID.pdf 7/20/1998
AP06/11/1998SCP23349023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s023_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP06/23/1998SLR23350024   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s024_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP07/27/1998SCP23351025   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s025_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP03/19/1998SCP23352026   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020406_s026_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP01/14/1999SLR3703027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20406-S030_Prevacid.pdf 1/14/1999
AP07/6/1999SE4859028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20406s28ltr.pdf 7/6/1999
AP07/6/1999SE4860028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20406S016.cfm 7/6/1999
AP011/20/1998SCS       
AP02/22/1999SLR3704030   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20406-S030_Prevacid.pdf 2/22/1999
AP011/15/1999SCM       
AP011/30/2000SE11379033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20406S33ltr.pdf 11/30/2000
AP011/30/2000SE11380033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20406S33lbl.pdf 11/30/2000
AP06/20/2000SLR3702034   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20406-S034_Prevacid.pdf 6/20/2000
AP06/2/2000SCM23353035   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020406_s035_Prevacid Caps.pdf 9/16/2009
AP011/15/1999SCS       
AP05/1/2001SE85455038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20406s38lbl.pdf 4/24/2003
AP05/1/2001SE86296038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20406S38ltr.pdf 7/31/2003
AP010/30/2000SCP23354039   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020406_s039_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP05/7/2001SCM       
AP06/29/2001SCP23355041   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020406_s041_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP012/8/2000SCS       
AP04/11/2001SCP23356043   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020406_s043_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP012/5/2001SCM23357044   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/020406_s044_Prevacid_Delayed_Release_Capsules.pdf 9/16/2009
AP05/3/2002SLR3872045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406s045and21281s002ltr.pdf 5/3/2002
AP05/3/2002SLR3873045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf 5/3/2002
AP03/7/2002SCS       
AP07/31/2002SE53700047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406se5-047LTR.pdf 7/31/2002
AP07/31/2002SE53701047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s47lbl.pdf 7/31/2002
AP012/3/2002SLR3871048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406slr048,21281slr004ltr.pdf 12/3/2002
AP012/3/2002SLR18551048   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020406_S048_PREVACID.pdf 11/19/2007
AP08/30/2002SLR11856052   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.cfm 6/23/2005
AP08/30/2002SLR3696052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf 8/30/2002
AP08/30/2002SLR3697052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf 8/30/2002
AP08/5/2003SLR6520055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf 8/15/2003
AP06/15/2004SLR9399056   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406slr056ltr.pdf 6/16/2004
AP06/15/2004SLR9411056   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20406slr056_prevacid_lbl.pdf 6/16/2004
AP06/17/2004SE59489057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf 12/21/2004
AP06/17/2004SE59496057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf 6/23/2004
AP04/12/2006SLR13926058   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf 4/13/2006
AP04/12/2006SLR13932058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf 4/13/2006
AP06/14/2007SLR16826064   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf 6/27/2007
AP06/14/2007SLR16925064   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf 7/5/2007
AP04/21/2008SLR19704065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf 4/23/2008
AP010/28/2008SLR21102067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf 10/29/2008
AP010/28/2008SLR21157067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf 11/7/2008
AP07/31/2009SLR23171071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf 8/13/2009
AP07/31/2009SLR23833071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf 11/12/2009
AP05/12/2010SLR25550073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s073,021428s020ltr.pdf 5/17/2010
AP05/12/2010SLR25569073   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s073,021428s020lbl.pdf 5/17/2010
AP09/3/2010SLR26435074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020406s074,021428s021ltr.pdf 9/9/2010
AP09/3/2010SLR26454074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020406s074,021428s021lbl.pdf 9/10/2010
AP06/1/2011SLR29023075   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s075,021428s022ltr.pdf 6/3/2011
AP06/1/2011SLR29033075   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s075,021428s022lbl.pdf 6/7/2011
AP010/28/2011SLR30438076   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s076ltr, 021428s023ltr.pdf 10/31/2011
AP010/28/2011SLR30449076   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s076,021428s023lbl.pdf 11/1/2011
AP05/20/2011SLR28941077   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020406s077,021428s024ltr.pdf 5/25/2011
AP05/20/2011SLR28966077   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020406s077,021428s024lbl.pdf 5/26/2011
AP09/28/2012SLR33885078   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s078-021428s025lbl.pdf 10/1/2012
AP09/28/2012SLR33899078   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406Orig1s078,021428Orig1s025ltr.pdf 10/2/2012
AP05/3/2012SLR32637079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020406s079,021428s026lbl.pdf 5/7/2012
AP05/3/2012SLR32665079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020406s079,021428s026ltr.pdf 5/9/2012
AP012/16/2015SLR44811080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020406s080-021428s027lbl.pdf 12/17/2015
AP012/16/2015SLR44818080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020406Orig1s080;021428Orig1s027ltr.pdf 12/18/2015
AP012/19/2014SLR41381081   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020406Orig1s081,021428Orig1s028ltr.pdf 12/24/2014
AP012/19/2014SLR41428081   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021428s028lbl020406s081lbl.pdf 12/29/2014
AP010/24/2016SLR47461082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021428Orig1s030,020406Orig1s082ltr.pdf 10/26/2016
AP010/24/2016SLR47535082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020406s082,021428s030lbl.pdf 10/31/2016




Back to FDA Applications sponsored by TAKEDA PHARMS USA

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.