Back to FDA Applications sponsored by MYLAN SPECLT

FDA Drug Application 020949 by MYLAN SPECLT

Application Number020949
Application Type New Drug Application
Sponsor ApplicantMYLAN SPECLT
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/30/2001N11057000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/20-949_AccuNeb.cfm 1/28/2005
AP01/22/2002SCS       
AP01/22/2002SCS       
AP02/20/2002SCS       
AP02/20/2002SCS       
AP08/6/2002SCM       
AP011/13/2002SCS       
AP06/2/2006SLR14233011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020949S011PI.pdf 6/6/2006
AP06/2/2006SLR14243011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/020949s011LTR.pdf 6/6/2006
AP03/2/2011SLR28105024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020949s024ltr.pdf 3/7/2011
AP03/2/2011SLR28121024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020949s024lbl.pdf 3/7/2011
AP09/30/2013SCM       
AP09/30/2013SCM       




Back to FDA Applications sponsored by MYLAN SPECLT

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.