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FDA Drug Application 050558 by IGI LABS INC

Application Number050558
Application Type New Drug Application
Sponsor ApplicantIGI LABS INC
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
AP010/19/1983N       
AP012/7/1983SLR       
AP012/22/1983SLR       
AP02/8/1984SCM       
AP02/17/1984SLR       
AP03/5/1984SLR       
AP04/18/1984SLR       
AP05/11/1984SLR       
AP08/20/1984SCM       
AP07/27/1984SCS       
AP04/3/1985SCM       
AP011/25/1985SCM       
AP01/23/1986SCP       
AP04/17/1986SCP       
AP05/30/1986SCS       
AP010/23/1986SLR       
AP05/12/1988SLR       
AP08/13/1987SCM       
AP08/28/1987SLR       
AP09/25/1987SCP       
AP03/24/1989SCS       
AP06/30/1989SLR       
AP03/22/1990SCM       
AP02/13/1992SCS       
AP02/13/1992SCS       
AP011/4/1992SCS       
AP010/23/1995SLR       
AP02/13/1992SCP       
AP08/14/1991SCM       
AP09/23/1992SCS       
AP02/18/1993SCM       
AP02/6/1995SLR       
AP012/31/1992SLR       
AP010/27/1994SLR       
AP06/28/1993SCS       
AP09/29/1995SLR       
AP012/23/1996SLR       
AP09/11/1996SLR       
AP010/31/1995SCM       
AP012/23/1996SLR       
AP04/3/1997SCM       
AP07/12/2001SLR       
AP010/12/2001SLR5562050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50558s50lbl.pdf 5/2/2003
AP04/13/2001SCS       
AP05/5/2001SCS       
AP011/9/2001SCS       
AP010/23/2002SCS       
AP05/19/2004SLR8632057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50558slr057,50643slr015ltr.pdf 5/26/2004
AP05/19/2004SLR8731057   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf 5/27/2004
AP07/30/2007SLR17429067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050558s067, 050643s021ltr.pdf 7/31/2007
AP07/30/2007SLR17432067   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf 7/31/2007
AP09/25/2014SLR40642069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050558Orig1s069,050643Orig1s022ltr.pdf 9/29/2014
AP09/25/2014SLR40657069   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050558s069,050643s022lbl.pdf 9/30/2014
AP08/14/2013SCM       
AP03/16/2015SCM       




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