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FDA Drug Application 103836 by VIDARA THERAPEUTICS RESEARCH LTD

Application Number103836
Application Type Biologic License Application
Sponsor ApplicantVIDARA THERAPEUTICS RESEARCH LTD
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP02/25/1999N16007000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109130.htm 3/9/2007
AP02/10/2000S78401001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/inteint021000L.htm 3/10/2004
AP011/24/2004S107365050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/103836_5050lbl.pdf 12/6/2004
AP011/24/2004S107375050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/103836_5050ltr.pdf 12/6/2004
AP01/26/2007S157865098   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/103836s5098ltr.pdf 2/12/2007
AP01/26/2007S159025098   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/103836s5098LBL.pdf 2/23/2007
AP08/27/2015SLR437485182   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/103836s5182lbl.pdf 8/28/2015
AP08/27/2015SLR437595182   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/103836Orig1s5182ltr.pdf 9/1/2015




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