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FDA Drug Application 019828 by FOUGERA PHARMS

Application Number019828
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
AP012/30/1988N       
AP07/7/1989SLR       
AP011/28/1989SCS       
AP08/18/1997SE1       
AP09/30/1992SE1       
AP06/7/1994SCM       
AP08/18/1997SE5       
AP08/8/1997SCM       
AP01/23/2004SLR7625009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19828slr009,20209slr005ltr.pdf 1/29/2004
AP01/23/2004SLR7651009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19828slr009,20209slr005_oxistat_lbl.pdf 2/2/2004




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