Back to FDA Applications sponsored by MERCK SHARP DOHME

FDA Drug Application 021337 by MERCK SHARP DOHME

Application Number021337
Application Type New Drug Application
Sponsor ApplicantMERCK SHARP DOHME
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
AP011/21/2001N1913000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21337ltr.pdf 11/9/2001
AP011/21/2001N1914000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21337lbl.pdf 11/9/2001
AP011/21/2001N1915000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21337_Invanz.cfm 11/9/2001
AP05/9/2002SCS       
AP05/9/2002SCS       
AP07/9/2002SCM       
AP012/20/2002SCS       
AP04/30/2004SLR8512013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21337slr013ltr.pdf 5/4/2004
AP05/20/2004SLR8640014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21337slr014ltr.pdf 5/26/2004
AP09/10/2004SLR10181015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21337s015ltr.pdf 9/10/2004
AP01/24/2005SLR11027017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21337s017ltr.pdf 1/26/2005
AP05/18/2005SE111671018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021337s018ltr.pdf 5/20/2005
AP05/18/2005SE111687018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s018lbl.pdf 5/20/2005
AP010/14/2005SE112897019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021337s019ltr.pdf 10/19/2005
AP010/14/2005SE112909019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021337s019lbl.pdf 10/19/2005
AP08/10/2006SE114661021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021337s021lbl.pdf 8/11/2006
AP08/10/2006SE114701021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021337s021LTR.pdf 8/14/2006
AP08/10/2006SE138296021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021337Orig1s021.pdf 1/16/2014
AP011/16/2007SLR18476026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021337s026ltr.pdf 11/19/2007
AP03/24/2008SLR19532028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021337s028ltr.pdf 3/26/2008
AP03/24/2008SLR19542028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021337s028lbl.pdf 3/27/2008
AP012/13/2009SLR24291030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021337s030lbl.pdf 12/15/2009
AP012/13/2009SLR24616030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021337s030ltr.pdf 1/25/2010
AP07/22/2011SLR29591031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021337s031ltr.pdf 7/25/2011
AP07/22/2011SLR29599031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021337s031lbl.pdf 7/25/2011
AP010/6/2009SLR23568033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/021337s033lbl.pdf 10/14/2009
AP010/6/2009SLR23787033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/021337s033ltr.pdf 11/10/2009
AP05/25/2010SLR25622034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021337s034ltr.pdf 5/27/2010
AP05/25/2010SLR25653034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021337s034lbl.pdf 5/28/2010
AP02/17/2012SLR31847037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s037lbl.pdf 2/22/2012
AP03/2/2012SLR32030038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021337s038ltr.pdf 3/5/2012
AP03/2/2012SLR32063038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021337s038lbl.pdf 3/7/2012
AP01/18/2013SCM       
AP08/5/2013SCM       
AP07/24/2013SLR36617041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021337Orig1s041ltr.pdf 7/26/2013
AP07/24/2013SLR36661041   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021337s041lbl.pdf 7/30/2013
AP09/30/2014SLR40689042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021337Orig1s042ltr.pdf 10/2/2014
AP09/30/2014SLR40700042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021337s042lbl.pdf 10/2/2014
AP03/16/2015SCM       




Back to FDA Applications sponsored by MERCK SHARP DOHME

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.