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FDA Drug Application 077237 by ROXANE

Application Number077237
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
TA011/4/2005TA13100000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077237TA_ltr.pdf 11/18/2005
AP16/6/2008N13100000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077237TA_ltr.pdf 11/18/2005
TA011/4/2005TA20119000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm 7/1/2008
AP16/6/2008N20119000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103285.htm 7/1/2008




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