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FDA Drug Application 078115 by TARO

Application Number078115
Application Type Abbreviated New Drug Application
Sponsor ApplicantTARO
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
AP03/31/2009N22209000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078115s000ltr.pdf 4/3/2009
AP03/31/2009N22263000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107834.htm 4/14/2009
AP03/31/2009N31561000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/078115Orig1s000BioeqR.pdf 1/27/2012
AP03/31/2009N34916000Approval Package  http://www.accessdata.fda.gov/drugsatfda_docs/anda/2009/078115Orig1s000Approv.pdf 1/22/2013




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