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FDA Drug Application 021535 by GALDERMA LABS LP

Application Number021535
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
AP07/24/2003N6148000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21535_clobex_lbl.pdf 7/28/2003
AP07/24/2003N6149000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21535ltr.pdf 7/28/2003
AP07/24/2003N9362000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-535_Clobex.cfm 6/14/2004
AP08/2/2012SLR33519002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s002ltr.pdf 8/20/2012
AP08/2/2012SLR33526002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535s002lbl.pdf 8/20/2012
AP011/30/2012SLR34517003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021535Orig1s003,021644Orig1s003ltr.pdf 12/3/2012
AP011/30/2012SLR38277003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021535Orig1s003, 021644Orig1s003lbl.pdf 1/14/2014




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