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FDA Drug Application 050578 by IGI LABS INC

Application Number050578
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 Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/19/1985N       
AP04/29/1993SLR       
AP04/29/1993SLR       
AP04/10/1990SCG       
AP03/22/1990SCM       
AP02/13/1992SCS       
AP09/7/1994SLR       
AP02/13/1992SCP       
AP08/9/1991SCM       
AP010/20/1994SLR       
AP012/31/1992SLR       
AP02/18/1993SCM       
AP09/11/1996SLR       
AP08/20/1996SLR       
AP01/26/1998SLR       
AP06/20/1996SLR       
AP06/20/1996SLR       
AP011/3/1995SCM       
AP010/4/1996SCS       
AP012/24/1996SLR       
AP04/3/1997SCM       
AP011/25/1997SCS       
AP03/29/2002SLR1945040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf 3/29/2002
AP03/29/2002SLR1946040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf 3/29/2002
AP03/22/2002SLR1951042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s042ltr.pdf 3/22/2002
AP02/22/2002SCS       
AP010/23/2002SCS       
AP05/19/2004SLR8630046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50578slr046,50634slr016ltr.pdf 5/26/2004
AP05/19/2004SLR8736046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50578slr046,50634slr016_fortaz_lbl.pdf 5/27/2004
AP03/14/2007SLR16014051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf 3/15/2007
AP07/9/2007SLR17273053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf 7/10/2007
AP07/9/2007SLR17276053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s053, 050634s020ltr.pdf 7/16/2007
AP09/24/2014SLR40616055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050578Orig1s055,050634Orig1s023ltr.pdf 9/26/2014
AP09/24/2014SLR40628055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf 9/26/2014
AP03/3/2015SCM       




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