Back to FDA Applications sponsored by JANSSEN PRODS

FDA Drug Application 021976 by JANSSEN PRODS

Application Number021976
Application Type New Drug Application
Sponsor ApplicantJANSSEN PRODS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/23/2006N14352000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021976s000LTR.pdf 6/27/2006
AP06/23/2006N14389000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976lbl.pdf 6/28/2006
AP06/23/2006N14786000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021976s000_SprycelTOC.cfm 9/6/2006
AP06/23/2006N15451000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109402.htm 12/8/2006
AP011/20/2006SLR15380001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021976s001lbl.pdf 11/22/2006
AP011/20/2006SLR15435001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021976s001ltr.pdf 12/4/2006
AP03/7/2008SLR19412003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s003, 021976s004ltr.pdf 3/11/2008
AP03/7/2008SLR19420003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf 3/12/2008
AP03/7/2008SLR19421004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s003s004lbl.pdf 3/12/2008
AP03/7/2008SLR19413004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s003, 021976s004ltr.pdf 3/11/2008
AP02/25/2008SCF19300005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s005lbl.pdf 2/26/2008
AP02/25/2008SCF19307005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s005ltr.pdf 2/27/2008
AP010/21/2008SE721073006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s006ltr.pdf 10/23/2008
AP010/21/2008SE521074007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s007ltr.pdf 10/23/2008
AP010/21/2008SE521188007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s007lbl.pdf 11/7/2008
AP012/18/2008SE521420009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021976s009ltr.pdf 12/29/2008
AP012/18/2008SE521450009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021976s009lbl.pdf 1/2/2009
AP06/16/2009SLR22771010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021976s010ltr.pdf 6/17/2009
AP06/16/2009SLR22791010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s010lbl.pdf 6/22/2009
AP06/15/2009SLR22772011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021976s011ltr.pdf 6/17/2009
AP06/15/2009SLR22790011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021976s011lbl.pdf 6/22/2009
AP01/27/2010SE824725012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s012s013ltr.pdf 2/5/2010
AP01/27/2010SE824712012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf 2/4/2010
AP01/27/2010SE824713013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s012s013lbl.pdf 2/4/2010
AP01/27/2010SE824726013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s012s013ltr.pdf 2/5/2010
AP04/26/2010SLR25387016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s016ltr.pdf 4/29/2010
AP04/26/2010SLR25409016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s016lbl.pdf 5/3/2010
AP012/13/2010SE227279017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021976s017lbl.pdf 12/13/2010
AP012/13/2010SE227284017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021976s017ltr.pdf 12/15/2010
AP010/19/2011SE830397018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021976s018ltr.pdf 10/24/2011
AP010/19/2011SE830425018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021976s018lbl.pdf 10/25/2011
AP012/16/2011SE831239020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202895,021976s020lbl.pdf 12/23/2011
AP012/16/2011SE831269020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202895s000,021976s020ltr.pdf 12/27/2011
AP02/13/2012SLR31779021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s021lbl.pdf 2/14/2012
AP02/13/2012SLR31792021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s021ltr.pdf 2/15/2012
AP02/17/2012SLR31873022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s022ltr.pdf 2/23/2012
AP02/17/2012SLR31886022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s022lbl.pdf 2/24/2012
AP011/9/2012SCM34387025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s025lbl.pdf 11/15/2012
AP06/1/2012SLR32815026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021976s026,202895s002lbl.pdf 6/6/2012
AP06/1/2012SLR32842026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021976s026,202895s002ltr.pdf 6/7/2012
AP04/24/2013SE835844027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202895Orig1s004,021976Orig1s027ltr.pdf 4/25/2013
AP04/24/2013SE835870027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s027,202895s004lbl.pdf 4/29/2013
AP02/1/2013SE235062028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s028,202895Orig1s005ltr.pdf 2/4/2013
AP02/1/2013SE235084028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s028,202895s005lbl.pdf 2/6/2013
AP02/1/2013SE235064029   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s029,202895Orig1s006ltr.pdf 2/4/2013
AP02/1/2013SE235083029   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s029,202895s006lbl.pdf 2/6/2013
AP02/22/2013SLR35237030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s030,202895Orig1s007ltr.pdf 2/26/2013
AP02/22/2013SLR35253030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s030,202895s007lbl.pdf 2/26/2013
AP06/14/2013SCM       
AP010/31/2013SCM       
AP011/7/2013SLR37769033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021976Orig1s033,202895Orig1s010ltr.pdf 11/8/2013
AP011/7/2013SLR37775033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021976s033_202895s010lbl.pdf 11/8/2013
AP04/7/2014SLR38996034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021976Orig1s034,202895Orig1s011_replace_ltr.pdf 4/8/2014
AP04/7/2014SLR39012034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021976s034,202895s011lbl.pdf 4/8/2014
AP05/8/2014SCM       
AP05/27/2015SLR42936036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s036,202895Orig1s013ltr.pdf 5/28/2015
AP05/27/2015SLR42940036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s036,202895s013lbl.pdf 5/29/2015
AP02/3/2015SCM       
AP02/19/2016SCM       
AP03/27/2015SLR42353039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021976Orig1s039,202895Orig1s016ltr.pdf 4/1/2015
AP03/27/2015SLR42400039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021976s039,202895s016lbl.pdf 4/2/2015
AP04/11/2016SCM       
AP06/17/2016SE846364043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s043,202895Orig1s017ltr.pdf 6/21/2016
AP06/17/2016SE846385043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s043,202895s017lbledt.pdf 6/21/2016
AP09/15/2016SLR47087044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021976Orig1s044,202895Orig1s019ltr.pdf 9/20/2016
AP09/15/2016SLR47110044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021976s044,202895s019lbl.pdf 9/20/2016




Back to FDA Applications sponsored by JANSSEN PRODS

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.