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FDA Drug Application 050643 by IGI LABS INC

Application Number050643
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
AP04/28/1989N       
AP01/15/1993SCS       
AP010/23/1995SLR       
AP03/30/1992SCM       
AP02/6/1995SLR       
AP010/27/1994SLR       
AP09/29/1995SLR       
AP012/23/1996SLR       
AP09/11/1996SLR       
AP012/23/1996SLR       
AP07/12/2001SLR       
AP010/12/2001SLR5563011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50643s11lbl.pdf 5/2/2003
AP04/13/2001SCS       
AP011/9/2001SCS       
AP05/19/2004SLR8633015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50558slr057,50643slr015ltr.pdf 5/26/2004
AP05/19/2004SLR8733015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50558slr057,50643slr015_zinacef_lbl.pdf 5/27/2004
AP07/30/2007SLR17430021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050558s067, 050643s021ltr.pdf 7/31/2007
AP07/30/2007SLR17431021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050558s067,050643s021lbl.pdf 7/31/2007
AP09/25/2014SLR40643022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050558Orig1s069,050643Orig1s022ltr.pdf 9/29/2014
AP09/25/2014SLR40656022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050558s069,050643s022lbl.pdf 9/30/2014
AP04/29/2013SCM       




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