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FDA Drug Application 089897 by ROXANE

Application Number089897
Application Type Abbreviated New Drug Application
Sponsor ApplicantROXANE
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
AP09/6/1988N15402000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm142827.htm 11/27/2006
AP09/6/1988N43162000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=RemsDetails.page&REMS=17 6/30/2015
AP06/15/1993SL       
AP06/15/1993SC       
AP06/15/1993SC       
AP04/23/1999SC       
AP04/23/1999SC       
AP01/29/1997SC       
AP01/29/1997SL       
AP01/29/1997SC       
AP08/28/1996SC       
AP03/12/1999SC       
AP03/12/1999SC       
AP02/1/2000SC       
AP09/5/2000SCA       
AP03/21/2001SCP       
AP04/16/2014SLR39240028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/089897Orig1s028lbl.pdf 5/6/2014




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