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FDA Drug Application 076184 by TEVA PHARMS

Application Number076184
Application Type Abbreviated New Drug Application
Sponsor ApplicantTEVA PHARMS
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
TA04/23/2002TA19063000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076184s000ltr.pdf 2/7/2008
TA04/23/2002TA19330000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 2/28/2008
TA04/23/2002TA27879000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/076184_original_approval_pkg.pdf 2/15/2011
TA04/23/2002TA27880000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/076184_original_approval_pkg.pdf 2/15/2011
AP12/6/2008N19063000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/076184s000ltr.pdf 2/7/2008
AP12/6/2008N19330000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101551.htm 2/28/2008
AP12/6/2008N27879000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/076184_original_approval_pkg.pdf 2/15/2011
AP12/6/2008N27880000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/076184_original_approval_pkg.pdf 2/15/2011
AP08/4/2008SL       
AP08/4/2008SCS       
AP08/4/2008SL       




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