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FDA Drug Application 020340 by FOUGERA PHARMS

Application Number020340
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
AP06/17/1994N       
AP05/3/1996SE2       
AP07/24/1995SLR       
AP011/15/1996SCM6435003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/020340s003_temovate_toc.cfm 8/7/2003
AP08/8/1997SCM       
AP04/2/2003SLR4906006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020340s006lbl.pdf 4/7/2003
AP04/2/2003SLR5377006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20340slr006ltr.pdf 4/18/2003
AP011/15/2012SLR34409007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020340Orig1s007ltr.pdf 11/16/2012
AP011/15/2012SLR34416007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020340s007lbl.pdf 11/16/2012




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