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FDA Drug Application 019957 by FOUGERA PHARMS

Application Number019957
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
AP012/14/1990N       
AP08/17/1995SLR       
AP010/7/1994SCS       
AP06/7/1994SCM       
AP010/7/1994SCM       
AP06/7/1995SCS       
AP011/12/1998SCM       
AP012/9/2001SLR5901007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf 6/10/2003
AP06/30/1999SCM       
AP012/9/2001SLR5902009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/19957s9lbl.pdf 6/10/2003
AP06/7/2000SCS       
AP01/18/2002SE58880011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf 6/2/2004
AP01/18/2002SE55005011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf 4/8/2003
AP02/18/2015SLR41872012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019957Orig1s012ltr.pdf 2/19/2015
AP02/18/2015SLR41887012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019957s012lbl.pdf 2/20/2015




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