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FDA Drug Application 008848 by FOUGERA PHARMS

Application Number008848
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
AP04/9/1953N       
AP011/28/1980SCE       
AP011/28/1980SLR       
AP011/28/1980S       
AP08/2/1989SPD       
AP09/4/1986SLR15223018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/008848_S018_Pamine Tablets_APPROVAL PACKAGE.pdf 10/25/2006
AP010/24/1997SCM       
AP011/8/1999SCM       
AP011/8/1999SCP       
AP06/22/2001SCF       
AP03/25/2003SCF9324024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/08848scf024ltr.pdf 6/14/2004
AP05/16/2005SCM11659025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/008848s025ltr.pdf 5/18/2005




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