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FDA Drug Application 019593 by IGI LABS INC

Application Number019593
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
AP012/17/1986N       
AP05/18/1987SCP       
AP01/4/1988SLR       
AP03/17/1989SLR       
AP05/20/1988SLR       
AP05/20/1988SLR       
AP08/8/1989SCM       
AP05/18/1989SLR       
AP08/13/1990SLR       
AP011/25/1991SLR       
AP07/16/1990SLR       
AP012/12/1990SCM       
AP01/17/1991SCS       
AP011/21/1990SLR       
AP012/20/1990SCM       
AP09/5/1991SLR       
AP02/18/1992SCP       
AP07/22/1992SCS       
AP04/5/1993SLR       
AP08/12/1992SCS       
AP08/10/1994SLR       
AP011/3/1994SLR       
AP010/29/1999SLR5552028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19593S28_zantacinjection.cfm 4/30/2003
AP010/29/1999SLR5553028   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19593S28_zantacivinjection_approv.pdf 4/30/2003
AP010/29/1999SLR12590028   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/019593s028lbl.pdf 10/29/1999
AP010/22/1999SLR       
AP010/22/1999SLR       
AP010/29/1999SLR       
AP05/9/2001SLR       
AP01/7/2002SLR2028033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19090s45ltr.pdf 1/7/2002
AP01/15/2002SCS       
AP012/13/2001SCM       
AP07/12/2006SLR14507038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019090s050, 019593s038_ltr.pdf 7/21/2006
AP02/17/2009SLR21869039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s051,019593s039ltr.pdf 2/19/2009
AP02/17/2009SLR22125039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s051,019593s039lbl.pdf 3/27/2009
AP09/4/2009SLR23542042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019090s053,019593s042lbl.pdf 10/6/2009
AP09/4/2009SLR23853042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019090s053,019593s042ltr.pdf 11/12/2009




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