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FDA Drug Application 076388 by TEVA

Application Number076388
Application Type Abbreviated New Drug Application
Sponsor ApplicantTEVA
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
AP08/30/2006N14852000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076388s000ltr.pdf 9/18/2006
AP08/30/2006N19033000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm100192.htm 2/1/2008
AP08/30/2006N31762000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2006/076388Orig1s000Approv.pdf 2/14/2012




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