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FDA Drug Application 021729 by OTSUKA

Application Number021729
Application Type New Drug Application
Sponsor ApplicantOTSUKA
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
AP06/7/2006N17732000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021729s000TOC.cfm 8/31/2007
AP06/7/2006N14252000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021729lbl.pdf 6/8/2006
AP06/7/2006N14293000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021729s000LTR.pdf 6/12/2006
AP06/7/2006N24805000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085804.pdf 2/17/2010
AP06/7/2006N31185000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP010/20/2006SLR15138001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021436s013,021713s008,021729s001lbl.pdf 10/23/2006
AP010/20/2006SLR15163001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021436s013, 021713s008, 021729s001ltr.pdf 10/23/2006
AP09/25/2007SLR18037002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf 9/26/2007
AP09/25/2007SLR18155002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf 10/4/2007
AP010/29/2007SE518314004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf 11/7/2007
AP010/29/2007SE518388004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017, 021713s012, 021729s004, 021866s004ltr.pdf 11/8/2007
AP011/16/2007SE118436005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf 11/19/2007
AP011/16/2007SE118478005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf 11/19/2007
AP05/6/2008SE220233006   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf 7/17/2008
AP05/6/2008SE231550006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021729Orig1s006_s007_s009.pdf 1/27/2012
AP05/6/2008SE219812006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf 5/14/2008
AP05/6/2008SE119813007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021713se1-015,021713s017,021729se2-006,021729se1-007.pdf 5/14/2008
AP05/6/2008SE131551007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021729Orig1s006_s007_s009.pdf 1/27/2012
AP05/6/2008SE120234007   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf 7/17/2008
AP02/27/2008SE519314008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf 2/28/2008
AP02/27/2008SE519344008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021, 021713s016, 021729s008, 021866s008ltr.pdf 2/29/2008
AP05/6/2008SLR20235009   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf 7/17/2008
AP05/6/2008SLR31552009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021729Orig1s006_s007_s009.pdf 1/27/2012
AP05/6/2008SLR19814009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf 5/14/2008
AP03/6/2008SLR19393010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf 3/7/2008
AP08/14/2008SLR20640012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf 8/19/2008
AP08/14/2008SLR20678012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf 8/26/2008
AP07/19/2009SLR23055013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf 7/23/2009
AP07/19/2009SLR23078013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf 7/24/2009
AP02/16/2011SE827929014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,021713s021,021866s016ltr.pdf 2/18/2011
AP02/16/2011SE827961014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf 2/24/2011
AP011/30/2010SLR27135015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf 12/2/2010
AP011/30/2010SLR27160015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,021713s022,021729s015ltr.pdf 12/3/2010
AP012/1/2010SLR27240016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,021713s023,021729s016ltr.pdf 12/7/2010
AP012/1/2010SLR27153016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf 12/3/2010
AP03/2/2011SLR28113017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf 3/7/2011
AP03/2/2011SLR28181017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,21713s024,21729s017ltr.pdf 3/8/2011
AP02/22/2012SLR31878018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf 2/24/2012
AP02/22/2012SLR31909018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,021713s025,021729s018ltr.pdf 2/27/2012
AP06/9/2014SLR39468020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf 6/10/2014
AP06/9/2014SLR39851020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713Orig1s028,021729Orig1s020,021866Orig1s021ltr.pdf 7/11/2014
AP07/30/2013SLR36682021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713Orig1s029,021729Orig1s021,021866Orig1s022ltr.pdf 8/5/2013
AP07/30/2013SLR36750021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf 8/9/2013
AP012/12/2014SE841244022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713Orig1s030,021729Orig1s022,021866Orig1s023ltr.pdf 12/15/2014
AP012/12/2014SE841252022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf 12/15/2014
AP01/15/2016SLR44984023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf 1/20/2016
AP01/15/2016SLR45009023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf 1/22/2016
AP08/18/2016SLR46821024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf 8/19/2016
AP08/18/2016SLR46848024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf 8/23/2016




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