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FDA Drug Application 021789 by GALDERMA LABS LP

Application Number021789
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
AP06/30/2005N11943000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789lbl.pdf 7/7/2005
AP06/30/2005N11959000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021789ltr.pdf 7/8/2005
AP06/30/2005N14998000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021789s000_MetrogelTOC.cfm 9/26/2006
AP011/14/2005SLR13112001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021789s001ltr.pdf 11/18/2005
AP011/14/2005SLR13119001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021789s001lbl.pdf 11/18/2005
AP03/5/2010SLR25009003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021789s003ltr.pdf 3/9/2010
AP03/5/2010SLR25053003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021789s003lbl.pdf 3/17/2010
AP010/19/2011SLR30394004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/021789s004ltr.pdf 10/24/2011
AP010/19/2011SLR30504004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021789s004lbl.pdf 11/4/2011
AP010/19/2011SLR34056004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/021789Orig1s004.pdf 10/12/2012
AP09/4/2014SCM       
AP01/12/2015SCM       




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