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FDA Drug Application 050805 by GALDERMA LABS LP

Application Number050805
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
AP05/26/2006N14187000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050805lbl.pdf 5/30/2006
AP05/26/2006N14188000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050805s000LTR.pdf 5/30/2006
AP05/26/2006N19263000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/050805s000TOC.cfm 2/22/2008
AP05/13/2010SLR25556002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050805s002ltr.pdf 5/17/2010
AP05/13/2010SLR25566002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050805s002lbl.pdf 5/17/2010
AP011/7/2012SLR34335007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/050805Orig1s007ltr.pdf 11/8/2012
AP011/7/2012SLR34343007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/050805s007lbl.pdf 11/8/2012
AP07/25/2013SLR36633008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050805Orig1s008ltr.pdf 7/29/2013
AP07/25/2013SLR36655008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050805s008lbl.pdf 7/30/2013
AP06/24/2015SCM       
AP09/3/2015SCM       




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