Back to FDA Applications sponsored by CORDEN PHARMA

FDA Drug Application 050665 by CORDEN PHARMA

Application Number050665
Application Type New Drug Application
Sponsor ApplicantCORDEN PHARMA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/23/1991N       
AP012/31/1992SE5       
AP05/17/1995SE5       
AP012/7/1993SCF       
AP012/7/1993SCP       
AP08/31/1995SLR       
AP08/31/1995SLR       
AP04/10/1995SCS       
AP02/8/1995SLR       
AP05/9/1995SLR       
AP012/26/1995SLR9244012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50665slr012ltr.pdf 6/9/2004
AP09/5/1996SE1       
AP02/7/1996SCS       
AP08/26/1997SLR       
AP04/23/1997SLR       
AP05/29/1997SLR       
AP01/5/1998SCM       
AP09/8/1998SCS       
AP05/13/1999SCP       
AP04/15/1999SCP       
AP010/1/2001SLR       
AP06/23/2004N9537023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50664slr023,50665slr023ltr.pdf 6/25/2004
AP06/23/2004N9558023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50664slr023,50665slr023_cefzil_lbl.pdf 6/25/2004
AP09/14/2007SLR17899024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050664s024,050665s024lbl.pdf 9/19/2007
AP09/14/2007SLR17988024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050664s024, 050665s024ltr.pdf 9/25/2007




Back to FDA Applications sponsored by CORDEN PHARMA

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.