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FDA Drug Application 021753 by GALDERMA LABS LP

Application Number021753
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
AP06/19/2007N16834000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021753lbl.pdf 6/27/2007
AP06/19/2007N16913000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021753s000ltr.pdf 7/5/2007
AP06/19/2007N19461000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2007/021753TOC.cfm 3/14/2008
AP09/1/2010SLR26374002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021753s002ltr.pdf 9/7/2010
AP09/1/2010SLR26407002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021753s002lbl.pdf 9/7/2010
AP02/27/2012SCM31927004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021753s004lbl.pdf 2/27/2012
AP06/13/2014SCM39572007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021753Orig1s007ltr.pdf 6/18/2014




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