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FDA Drug Application 021302 by VALEANT BERMUDA

Application Number021302
Application Type New Drug Application
Sponsor ApplicantVALEANT BERMUDA
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
AP012/13/2001N1748000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-302_ELIDEL_Approv.pdf 12/13/2001
AP012/13/2001N1749000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21302lbl.pdf 12/13/2001
AP012/13/2001N1750000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-302_Elidel.cfm 12/13/2001
AP012/13/2001N27520000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088587.pdf 1/13/2011
AP011/15/2002SCM       
AP010/15/2003SCP6816004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21302scp004ltr.pdf 10/17/2003
AP010/15/2003SCP6824004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/21302scp004_elidel_lbl.pdf 10/17/2003
AP011/24/2004SLR10674005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21302s005ltr.pdf 12/2/2004
AP011/24/2004SLR10717005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21302s005lbl.pdf 12/3/2004
AP01/19/2006SLR13420011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021302s011lbl.pdf 1/19/2006
AP01/19/2006SLR13550011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021302s011ltr.pdf 1/30/2006
AP08/10/2007SLR17606012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021302s012ltr.pdf 8/14/2007
AP08/10/2007SLR17621012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021302s012lbl.pdf 8/14/2007
AP07/20/2010SLR25990014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021302s014lbl.pdf 7/22/2010
AP07/20/2010SLR26004014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021302s014ltr.pdf 7/23/2010
AP03/28/2014SLR38938018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021302s018lbl.pdf 4/1/2014
AP03/28/2014SLR38954018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021302Orig1s018ltr.pdf 4/2/2014
AP06/4/2014SCM       
AP09/26/2014SCM       
AP08/21/2014SCM       
AP010/11/2016SCM       
AP06/9/2016SCM       




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