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FDA Drug Application 019323 by FOUGERA PHARMS

Application Number019323
Application Type New Drug Application
Sponsor ApplicantFOUGERA PHARMS
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
AP012/27/1985N       
AP04/9/1987SCS       
AP07/10/1987SCS       
AP03/3/1987SCP       
AP012/7/1989SLR       
AP08/13/1987SCE       
AP012/7/1989SLR       
AP012/7/1989SLR       
AP04/17/1992SCM       
AP08/30/1995SLR       
AP03/5/1993SCS       
AP08/23/1993SCS       
AP06/7/1994SCM       
AP06/29/1994SCS       
AP011/15/1996SCM6357016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/019323-S16_Temovate Ointment 0.05%_toc.cfm 8/5/2003
AP06/1/1998SCM       
AP04/2/2003SLR4912019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019322s018lbl.pdf 4/7/2003
AP04/2/2003SLR5369019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19322slr018,19323slr019ltr.pdf 4/18/2003




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