Back to FDA Applications sponsored by GALDERMA LABS LP

FDA Drug Application 021835 by GALDERMA LABS LP

Application Number021835
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
AP010/27/2005N12994000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021835lbl.pdf 11/1/2005
AP010/27/2005N13008000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021835ltr.pdf 11/1/2005
AP010/27/2005N16876000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021835s000TOC.cfm 7/3/2007
AP01/12/2011SCM27523002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf 1/14/2011
AP01/12/2011SCM27527002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf 1/14/2011
AP01/12/2011SLR27524004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021835s002s004lbl.pdf 1/14/2011
AP01/12/2011SLR27528004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021835s002,s004ltr.pdf 1/14/2011
AP09/7/2012SLR33691006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s006ltr.pdf 9/10/2012
AP09/7/2012SLR33717006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s006lbl.pdf 9/11/2012
AP08/17/2012SLR33522007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021835Orig1s007ltr.pdf 8/20/2012
AP08/17/2012SLR33525007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021835s007lbl.pdf 8/20/2012
AP04/7/2015SCM       
AP05/21/2015SCM       
AP04/15/2016SCM       




Back to FDA Applications sponsored by GALDERMA LABS LP