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FDA Drug Application 050634 by IGI LABS INC

Application Number050634
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       
AP09/7/1994SLR       
AP03/1/1993SCS       
AP011/8/1993SLR       
AP010/20/1994SLR       
AP08/20/1996SLR       
AP01/26/1998SLR       
AP06/20/1996SLR       
AP06/20/1996SLR       
AP09/11/1996SLR       
AP012/24/1996SLR       
AP011/25/1997SCS       
AP03/29/2002SLR1947012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s40ltr.pdf 3/29/2002
AP03/29/2002SLR1948012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50578s40lbl.pdf 3/29/2002
AP03/22/2002SLR1952014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50578s042ltr.pdf 3/22/2002
AP02/22/2002SCS       
AP05/19/2004SLR8631016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50578slr046,50634slr016ltr.pdf 5/26/2004
AP05/19/2004SLR8737016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50578slr046,50634slr016_fortaz_lbl.pdf 5/27/2004
AP03/14/2007SLR16013018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s051,050634s018lbl.pdf 3/15/2007
AP03/14/2007SLR16015018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s051,050634s018lbl.pdf 3/15/2007
AP07/9/2007SLR17272020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/050578s053,050634s020lbl.pdf 7/10/2007
AP07/9/2007SLR17275020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/050578s053, 050634s020ltr.pdf 7/16/2007
AP09/24/2014SLR40617023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050578Orig1s055,050634Orig1s023ltr.pdf 9/26/2014
AP09/24/2014SLR40627023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050578s055,050634s023lbledt.pdf 9/26/2014
AP04/29/2013SCM       
AP04/11/2014SCM       




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