Back to FDA Applications sponsored by SOMERSET

FDA Drug Application 021708 by SOMERSET

Application Number021708
Application Type New Drug Application
Sponsor ApplicantSOMERSET
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New indication
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/27/2006N13712000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf 3/3/2006
AP19/10/2014N13712000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021708s000_021336s000lbl.pdf 3/3/2006
AP02/27/2006N13718000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021708s000_021336s000ltr.pdf 3/3/2006
AP19/10/2014N13718000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021708s000_021336s000ltr.pdf 3/3/2006
AP02/27/2006N15836000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088589.pdf 2/20/2007
AP19/10/2014N15836000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088589.pdf 2/20/2007
AP02/27/2006N16500000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP19/10/2014N16500000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/UCM096273 5/9/2007
AP02/27/2006N17813000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021336s000_021708s000TOC.cfm 9/10/2007
AP19/10/2014N17813000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/021336s000_021708s000TOC.cfm 9/10/2007
AP02/27/2006N40492000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf 9/16/2014
AP19/10/2014N40492000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021336Orig1s005,s010,021708Orig1s000ltr.pdf 9/16/2014
AP02/27/2006N40659000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf 9/30/2014
AP19/10/2014N40659000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021336s005s010,021708s000lbl.pdf 9/30/2014




Back to FDA Applications sponsored by SOMERSET

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.