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FDA Drug Application 075710 by IMPAX LABS INC

Application Number075710
Application Type Abbreviated New Drug Application
Sponsor ApplicantIMPAX LABS INC
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
TA012/27/2002TA19064000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075710s000ltr.pdf 2/7/2008
TA012/27/2002TA19329000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 2/28/2008
TA012/27/2002TA32292000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/075710Orig1s000.pdf 3/30/2012
AP12/6/2008N19064000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/075710s000ltr.pdf 2/7/2008
AP12/6/2008N19329000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 2/28/2008
AP12/6/2008N32292000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/075710Orig1s000.pdf 3/30/2012




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