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FDA Drug Application 050783 by GALDERMA LABS LP

Application Number050783
Application Type New Drug Application
Sponsor ApplicantGALDERMA LABS LP
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
AP02/2/2001N1524000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/50783ltr.pdf 2/2/2001
AP02/2/2001N1525000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/50783LBL.pdf 2/2/2001
AP02/2/2001N3388000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/50-783_Periostat.cfm 2/2/2001
AP07/19/2001SCS       
AP03/31/2004SLR8211002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50783slr002_periostat_lbl.pdf 4/5/2004
AP03/31/2004SLR8293002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50783slr002ltr.pdf 4/7/2004




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