Back to FDA Applications sponsored by ALVOGEN MALTA

FDA Drug Application 018751 by ALVOGEN MALTA

Application Number018751
Application Type New Drug Application
Sponsor ApplicantALVOGEN MALTA
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
AP012/23/1982N       
AP05/22/1985SLR       
AP01/8/1985SCS       
AP06/28/1985SCP       
AP012/18/1986SCM       
AP04/25/1990SLR       
AP03/9/1990SCS       
AP09/10/1992SCS       
AP02/24/1995SLR       
AP011/17/1995SCM       
AP07/23/1998SCM       
AP03/20/2001SCP       
AP04/4/2001SCS       
AP07/11/2001SCS       
AP03/28/2014SLR38936023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/018751s023lbledt.pdf 4/1/2014
AP03/28/2014SLR38953023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/018751Orig1s023ltr.pdf 4/2/2014




Back to FDA Applications sponsored by ALVOGEN MALTA

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.