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FDA Drug Application 021152 by FOUGERA PHARMS

Application Number021152
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
AP03/31/2005N11350000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021152ltr.pdf 4/6/2005
AP03/31/2005N17810000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021152s000TOC.cfm 9/10/2007
AP09/3/2010SLR26416002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021152s002lbl.pdf 9/7/2010
AP09/3/2010SLR26421002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021152s002ltr.pdf 9/8/2010
AP012/19/2014SCM       
AP01/16/2015SE841649004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021152Orig1s004ltr.pdf 1/20/2015
AP01/16/2015SE841654004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021152s004lbl.pdf 1/20/2015
AP05/12/2011SLR28810005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021152s005ltr.pdf 5/16/2011
AP05/12/2011SLR28830005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021152s005lbl.pdf 5/16/2011
AP04/24/2013SCM       
AP04/1/2013SCM       
AP011/17/2014SCM       




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