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FDA Drug Application 021112 by GALDERMA LABS LP

Application Number021112
Application Type New Drug Application
Sponsor ApplicantGALDERMA LABS LP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/18/2002N4037000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21112ltr.pdf 1/18/2002
AP01/18/2002N4038000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21112lbl.pdf 1/18/2002
AP01/18/2002N4039000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-112_Tri-Luma.cfm 3/26/2002
AP012/20/2012SLR34759006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021112Orig1s006ltr.pdf 12/26/2012
AP11/16/2013SLR34759006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021112Orig1s006ltr.pdf 12/26/2012
AP012/20/2012SLR34920006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021112s006lbl.pdf 1/22/2013
AP11/16/2013SLR34920006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021112s006lbl.pdf 1/22/2013
AP012/20/2012SLR34992006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021112Orig1s006ltr.pdf 1/28/2013
AP11/16/2013SLR34992006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021112Orig1s006ltr.pdf 1/28/2013
AP07/12/2013SCM       
AP010/18/2013SCM       
AP03/31/2014SLR38933009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021112s009lbl.pdf 4/1/2014
AP03/31/2014SLR38957009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021112Orig1s009ltr.pdf 4/2/2014
AP011/10/2014SCM       
AP01/20/2015SCM       




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