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FDA Drug Application 021644 by GALDERMA LABS

Application Number021644
Application Type New Drug Application
Sponsor ApplicantGALDERMA LABS
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
AP02/5/2004N7745000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21644ltr.pdf 2/27/2004
AP02/5/2004N7821000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21644_clobex_lbl.pdf 3/3/2004
AP02/5/2004N10745000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-644_Clobex.cfm 12/7/2004
AP08/17/2012SLR33521002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021644Orig1s002ltr.pdf 8/20/2012
AP08/17/2012SLR33524002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021644s002lbl.pdf 8/20/2012
AP011/30/2012SLR34518003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s003,021644Orig1s003ltr.pdf 12/3/2012
AP011/30/2012SLR38276003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf 1/14/2014




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