Back to FDA Applications sponsored by IGI LABS INC

FDA Drug Application 019090 by IGI LABS INC

Application Number019090
Application Type New Drug Application
Sponsor ApplicantIGI LABS INC
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
AP010/19/1984N       
AP04/16/1985SCM       
AP08/8/1985SCP       
AP02/28/1986SCM       
AP04/9/1987SCP       
AP04/9/1987SCM       
AP08/8/1986SCS       
AP03/3/1988SCP       
AP04/9/1987SLR       
AP011/24/1987SCM       
AP05/19/1988SLR       
AP03/17/1989SLR       
AP05/20/1988SLR       
AP05/20/1988SLR       
AP03/17/1989SLR       
AP08/13/1990SE2       
AP09/26/1990SCP       
AP08/8/1989SCM       
AP05/18/1989SLR       
AP06/25/1990SCS       
AP011/25/1991SLR       
AP07/16/1990SLR       
AP012/12/1990SCM       
AP011/21/1990SLR       
AP05/19/1992SCP       
AP012/20/1990SCM       
AP09/5/1991SLR       
AP07/22/1992SCS       
AP04/5/1993SLR       
AP011/3/1994SLR       
AP010/29/1999SLR5512037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19090s37_zantacinjection.cfm 4/29/2003
AP010/29/1999SLR9654037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19090s37_zantacinjection_approv.pdf 7/1/2004
AP01/14/1998SCS       
AP010/22/1999SLR       
AP010/22/1999SLR       
AP011/6/2001SCM       
AP04/2/1999SCM       
AP010/29/1999SLR       
AP05/9/2001SLR       
AP01/7/2002SLR2027045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19090s45ltr.pdf 1/7/2002
AP01/15/2002SCS       
AP03/14/2002SCP       
AP07/12/2006SLR14508050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019090s050, 019593s038_ltr.pdf 7/21/2006
AP02/17/2009SLR21868051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s051,019593s039ltr.pdf 2/19/2009
AP02/17/2009SLR22126051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.pdf 3/27/2009
AP09/4/2009SLR23541053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.pdf 10/6/2009
AP09/4/2009SLR23852053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s053,019593s042ltr.pdf 11/12/2009




Back to FDA Applications sponsored by IGI LABS INC

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.