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FDA Drug Application 021385 by VALEANT LUXEMBOURG

Application Number021385
Application Type New Drug Application
Sponsor ApplicantVALEANT LUXEMBOURG
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP012/10/2003N7137000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21385_Ertaczo_lbl.pdf 12/10/2003
AP012/10/2003N7253000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21385ltr.pdf 12/16/2003
AP012/10/2003N7833000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/21-385_Ertaczo.cfm 3/8/2004
AP011/22/2005SCS13169003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021385s003ltr.pdf 11/30/2005
AP01/22/2014SLR38349005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021385Orig1s005ltr.pdf 1/23/2014
AP01/22/2014SLR38355005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021385s005lbl.pdf 1/23/2014




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