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FDA Drug Application 021415 by GALDERMA LABS LP

Application Number021415
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
AP07/27/2004N9915000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21415ltr.pdf 7/30/2004
AP07/27/2004N9920000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21415lbl.pdf 7/30/2004
AP07/27/2004N13771000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021415s000_MetvixiaTOC.cfm 3/21/2006
AP05/31/2005SLR11751001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021415s001ltr.pdf 6/7/2005
AP05/31/2005SLR11767001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021415s001lbl.pdf 6/7/2005
AP06/26/2008SE820098003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021415s003ltr.pdf 6/30/2008
AP06/26/2008SE820113003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021415s003lbl.pdf 6/30/2008
AP011/20/2012SLR34447004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021415Orig1s004ltr.pdf 11/23/2012
AP011/20/2012SLR34490004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021415s004lbl.pdf 11/28/2012




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