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FDA Drug Application 019958 by FOUGERA PHARMS

Application Number019958
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
AP012/18/1990N       
AP02/14/1991SCS       
AP02/14/1991SCS       
AP010/7/1994SCS       
AP06/7/1994SCM       
AP010/7/1994SCM       
AP06/7/1995SCS       
AP06/17/1999SE591008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/19958s08ltr.pdf 6/17/1999
AP06/17/1999SE592008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19958S8_Cutivate.cfm 6/17/1999
AP06/17/1999SE593008   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/19958s8lbl.pdf 6/17/1999
AP04/25/1997SE5       
AP08/8/1997SCM       
AP06/17/1999SLR964011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19957s11ltr.pdf 6/17/1999
AP06/17/1999SLR965011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19957s11lbl.pdf 6/17/1999
AP01/21/1999SCM       
AP04/16/2002SLR2650013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19958s13ltr.pdf 4/16/2002
AP04/16/2002SLR2651013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19958s13lbl.pdf 4/16/2002
AP06/7/2000SCS       
AP09/3/2010SLR26412017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019958s017lbl.pdf 9/7/2010
AP09/3/2010SLR26419017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/019958s017ltr.pdf 9/8/2010




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