Back to FDA Applications sponsored by CUMBERLAND PHARMS

FDA Drug Application 021697 by CUMBERLAND PHARMS

Application Number021697
Application Type New Drug Application
Sponsor ApplicantCUMBERLAND PHARMS
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
AP012/29/2005N13313000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021697lbl.pdf 12/30/2005
AP012/29/2005N13350000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021697s000.pdf 1/6/2006
AP012/29/2005N13832000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021697s000_VaprisolTOC.cfm 3/24/2006
AP010/8/2008SCF21021001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021697s001ltr.pdf 10/14/2008
AP010/8/2008SCF21179001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021697s001lbl.pdf 11/7/2008
AP05/27/2010SLR25664002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021697s002ltr.pdf 6/2/2010
AP05/27/2010SLR25701002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021697s002lbl.pdf 6/3/2010
AP02/1/2012SLR31641003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021697s003ltr.pdf 2/3/2012
AP02/1/2012SLR31687003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021697s003lbl.pdf 2/6/2012
AP010/14/2016SLR47369005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021697Orig1s005ltr.pdf 10/17/2016
AP010/14/2016SLR47377005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021697s005lbl.pdf 10/17/2016




Back to FDA Applications sponsored by CUMBERLAND PHARMS

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.