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FDA Drug Application 018702 by FOUGERA PHARMS

Application Number018702
Application Type New Drug Application
Sponsor ApplicantFOUGERA PHARMS
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
AP012/14/1982N       
AP011/7/1983SLR       
AP05/20/1986SCS       
AP01/16/1991SCM       
AP06/7/1994SCM       
AP04/26/1996SLR       
AP06/22/1994SCS       
AP04/2/2003SLR8806007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf 5/28/2004
AP04/2/2003SLR8807007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf 5/28/2004
AP07/26/2002SCM8578008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18707slr008,18702slr007ltr.pdf 5/25/2004
AP07/26/2002SCM8579008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018707s008lbl.pdf 5/25/2004
AP04/5/2011SLR28473011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/018702s011lbl.pdf 4/6/2011
AP04/5/2011SLR28490011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/018707s012,018702s011ltr.pdf 4/11/2011




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