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FDA Drug Application 020901 by GALDERMA LABS LP

Application Number020901
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
AP011/24/1998N547000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20901ltr.pdf 11/24/1998
AP011/24/1998N548000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20901.cfm 7/8/1999
AP011/24/1998N549000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20901lbl.pdf 11/24/1998
AP012/6/2002SCM       
AP05/11/2004SLR8647002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20901slr002ltr.pdf 5/26/2004
AP05/11/2004SLR8706002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20901slr002_metrolotion_lbl.pdf 5/27/2004
AP01/12/2015SLR       




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