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FDA Drug Application 076765 by TEVA PHARMS USA

Application Number076765
Application Type Abbreviated New Drug Application
Sponsor ApplicantTEVA PHARMS USA
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
AP05/22/2006N14171000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076765LTR.pdf 5/25/2006
AP12/6/2007N14171000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076765LTR.pdf 5/25/2006
TA27/1/2009TA14171000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076765LTR.pdf 5/25/2006
AP33/14/2012N14171000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/076765LTR.pdf 5/25/2006
AP05/22/2006N14221000   http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053342.htm 6/6/2006
AP12/6/2007N14221000   http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053342.htm 6/6/2006
TA27/1/2009TA14221000   http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053342.htm 6/6/2006
AP33/14/2012N14221000   http://www.fda.gov/Drugs/DrugSafety/PublicHealthAdvisories/ucm053342.htm 6/6/2006
AP05/22/2006N28764000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076765s000TAltr.pdf 5/10/2011
AP12/6/2007N28764000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076765s000TAltr.pdf 5/10/2011
TA27/1/2009TA28764000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076765s000TAltr.pdf 5/10/2011
AP33/14/2012N28764000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/076765s000TAltr.pdf 5/10/2011
AP05/22/2006N32130000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076765Orig1s000ltr.pdf 3/16/2012
AP12/6/2007N32130000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076765Orig1s000ltr.pdf 3/16/2012
TA27/1/2009TA32130000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076765Orig1s000ltr.pdf 3/16/2012
AP33/14/2012N32130000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/076765Orig1s000ltr.pdf 3/16/2012




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