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FDA Drug Application 021281 by TAKEDA PHARMS NA

Application Number021281
Application Type New Drug Application
Sponsor ApplicantTAKEDA PHARMS NA
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
AP05/3/2001N3877000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21281_Prevacid_Aprov.pdf 5/3/2001
AP05/3/2001N3878000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21281lbl.pdf 5/3/2001
AP05/3/2001N3879000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21281_Prevacid.cfm 5/3/2001
AP05/3/2001N31069000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm213259.htm 12/20/2011
AP012/7/2001SCS       
AP05/3/2002SLR3875002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406s045and21281s002ltr.pdf 5/3/2002
AP05/3/2002SLR3876002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20406s45lbl.pdf 5/3/2002
AP03/7/2002SCS       
AP012/3/2002SLR3874004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20406slr048,21281slr004ltr.pdf 12/3/2002
AP012/3/2002SLR18503004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021281_S004_PREVACID.pdf 11/19/2007
AP012/3/2002SCE       
AP08/30/2002SLR3698007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21428,20406s052,21281s007ltr.pdf 8/30/2002
AP08/30/2002SLR3699007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21-428lbl.pdf 8/30/2002
AP08/30/2002SLR11857007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21428_20406s052_21281s007_PrevacidTOC.cfm 6/23/2005
AP08/5/2003SLR6519009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21428slr001,21281slr009,20406slr055ltr.pdf 8/15/2003
AP06/15/2004SLR       
AP06/17/2004SE89490014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/020406s057_021281s014_021428s004lbl%20.pdf 12/21/2004
AP06/17/2004SE89497014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20406se5-057,21281se8-014,21428se8-004ltr.pdf 6/23/2004
AP06/17/2004SE820358014   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021281_s014_PREVACID DELAYED REL CAPS.pdf 7/31/2008
AP04/12/2006SLR13925017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020406s058,021281s017,021428s006lbl.pdf 4/13/2006
AP04/12/2006SLR13931017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020406s058, 021281s017, 021428s006ltr.pdf 4/13/2006
AP06/14/2007SLR16827021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020406s064,021281s021,021428s012lbl.pdf 6/27/2007
AP06/14/2007SLR16924021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020406s064, 021281s021, 021428s012ltr.pdf 7/5/2007
AP04/21/2008SLR19703022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021281s022, 020406s065, 021428s013ltr.pdf 4/23/2008
AP010/28/2008SLR21103024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020406s067, 021281s024, 021428s017ltr.pdf 10/29/2008
AP010/28/2008SLR21156024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020406s067,021281s024,021428s017lbl.pdf 11/7/2008
AP07/31/2009S23172026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020406s071,021281s026,021428s019lbl.pdf 8/13/2009
AP07/31/2009S23834026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020406s071,021281s026,021428s019ltr.pdf 11/12/2009




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