Back to FDA Applications sponsored by OTSUKA

FDA Drug Application 021866 by OTSUKA

Application Number021866
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
AP09/20/2006N14931000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021866lbl.pdf 9/21/2006
AP09/20/2006N14957000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021866s000ltr.pdf 9/25/2006
AP09/20/2006N20578000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021866TOC.cfm 8/11/2008
AP09/20/2006N20579000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021866s000_SumR.pdf 8/12/2008
AP09/20/2006N24806000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm085804.pdf 2/17/2010
AP09/20/2006N31186000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm094303.htm 12/22/2011
AP09/25/2007SLR18038002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf 9/26/2007
AP09/25/2007SLR18153002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf 10/4/2007
AP09/25/2007SLR24753003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s016,021713s010,021729s002,021866s3s2ltr.pdf 2/14/2010
AP09/25/2007SLR24754003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021866s2s3,021729s2,021713s10,021436s16lbl.pdf 2/14/2010
AP010/29/2007SE518315004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s017,021713s012,21729s004,021866s004lbl.pdf 11/7/2007
AP010/29/2007SE518389004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s017, 021713s012, 021729s004, 021866s004ltr.pdf 11/8/2007
AP011/16/2007SE118435005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021436s018,021713s013,21729s005,021866s005lbl.pdf 11/19/2007
AP011/16/2007SE118479005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021436s018, 021866s005, 021729s005, 021713s013ltr.pdf 11/19/2007
AP05/6/2008SE219815006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf 5/14/2008
AP05/6/2008SE220231006   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf 7/17/2008
AP05/6/2008SE231553006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021866Orig1s006_s007_s009.pdf 1/27/2012
AP05/6/2008SE131554007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021866Orig1s006_s007_s009.pdf 1/27/2012
AP05/6/2008SE120232007   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf 7/17/2008
AP05/6/2008SE119816007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf 5/14/2008
AP02/27/2008SE519313008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s21,021713s16,021729s8,021866s8lbl.pdf 2/28/2008
AP02/27/2008SE519345008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s021, 021713s016, 021729s008, 021866s008ltr.pdf 2/29/2008
AP05/6/2008SLR19817009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021729s009,021866se2-006,021866se1-007,021866s009ltr.pdf 5/14/2008
AP05/6/2008SLR20230009   http://www.accessdata.fda.gov/drugsatfda_docs/summary_review/2008/021729s6s7s9,21866s6s7s9SUMR.pdf 7/17/2008
AP05/6/2008SLR31555009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/021866Orig1s006_s007_s009.pdf 1/27/2012
AP03/6/2008SLR19394010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s023,021713s018,021729s010,021866s010ltr.pdf 3/7/2008
AP08/14/2008SLR20641013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021436s026,021713s019,021729s012,021866s013ltr.pdf 8/19/2008
AP08/14/2008SLR20676013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021436s026,021729s012,021713s019,021866s013lbl.pdf 8/26/2008
AP07/19/2009SLR23054014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021436s028,021713s020,021729s013,021866s014lbl.pdf 7/23/2009
AP07/19/2009SLR23079014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021436s028,021713s020,021729s013,021866s014ltr.pdf 7/24/2009
AP02/3/2010SLR24792015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021866s015ltr.pdf 2/17/2010
AP02/16/2011SE827931016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s029,021729s014,021713s021,021866s016ltr.pdf 2/18/2011
AP02/16/2011SE827949016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s029,021713s021,021729s014,021866s016lbl.pdf 2/24/2011
AP011/30/2010SLR27140017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s030,021866s017,021713s022,021729s015lbl.pdf 12/2/2010
AP011/30/2010SLR27158017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s030,021866s017,021713s022,021729s015ltr.pdf 12/3/2010
AP012/1/2010SLR27238018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021436s031,021866s018,021713s023,021729s016ltr.pdf 12/7/2010
AP012/1/2010SLR27155018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021436s031,021866s018,021713s023,021729s016lbl.pdf 12/3/2010
AP03/2/2011SLR28115019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021436s032,021866s019,021713s024,021729s017lbl.pdf 3/7/2011
AP03/2/2011SLR28179019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021436s032,21866s019,21713s024,21729s017ltr.pdf 3/8/2011
AP02/22/2012SLR31879020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021436s034,021713s025,021729s018,021866s020lbl.pdf 2/24/2012
AP02/22/2012SLR31907020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021436s034,021866s020,021713s025,021729s018ltr.pdf 2/27/2012
AP06/9/2014SLR39469021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s036,021866s021,021729s020,021713s028lbl.pdf 6/10/2014
AP06/9/2014SLR39852021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s036,021713Orig1s028,021729Orig1s020,021866Orig1s021ltr.pdf 7/11/2014
AP07/30/2013SLR36683022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021436Orig1s037,021713Orig1s029,021729Orig1s021,021866Orig1s022ltr.pdf 8/5/2013
AP07/30/2013SLR36749022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021436s037,021713s029,021729s021,021866s022lbl.pdf 8/9/2013
AP012/12/2014SE841245023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021436Orig1s038,021713Orig1s030,021729Orig1s022,021866Orig1s023ltr.pdf 12/15/2014
AP012/12/2014SE841251023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021436s038,021713s030,021729s022,021866s023lbl.pdf 12/15/2014
AP02/3/2015SCM       
AP01/15/2016SLR44985025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s040,021713Orig1s031,021729Orig1s023,021866Orig1s025,0202971Orig1s008ltr.pdf 1/20/2016
AP01/15/2016SLR45010025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/21436s04021713s03121729s02321866s025lbl.pdf 1/22/2016
AP08/18/2016SLR46822026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021436Orig1s041,021713Orig1s032,021729Orig1s024,021866Orig1s026,202971Orig1s009ltr.pdf 8/19/2016
AP08/18/2016SLR46847026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021436s041,021713s032,021729s024,021866s026lbl.pdf 8/23/2016




Back to FDA Applications sponsored by OTSUKA

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.