Back to FDA Applications sponsored by HEYL CHEMISCH

FDA Drug Application 021626 by HEYL CHEMISCH

Application Number021626
Application Type New Drug Application
Sponsor ApplicantHEYL CHEMISCH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/2/2003N6732000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021626lbl.pdf 10/2/2003
AP010/2/2003N6769000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21626ltr.pdf 10/2/2003
AP010/2/2003N7460000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-626_Radiogardase.cfm 12/31/2003
AP05/11/2004SCM8635001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21626scp001ltr.pdf 5/26/2004
AP09/24/2004SCM       
AP06/30/2005SCM       
AP09/12/2005SCM       
AP011/20/2006SCM       
AP02/15/2008SCM       
AP08/25/2008SCM20689007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021626s007ltr.pdf 8/27/2008
AP08/25/2008SCM20707007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021626s007lbl.pdf 8/29/2008
AP09/12/2008SCM       
AP08/20/2014SLR40310010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021626s010lbl.pdf 8/22/2014




Back to FDA Applications sponsored by HEYL CHEMISCH

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.