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FDA Drug Application 079166 by TEVA PHARMS USA

Application Number079166
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
TA05/12/2010TA25558000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079166s000ltr.pdf 5/17/2010
TA05/12/2010TA46562000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079166Orig1s000ltr.pdf 7/20/2016
TA13/11/2014TA25558000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079166s000ltr.pdf 5/17/2010
TA13/11/2014TA46562000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079166Orig1s000ltr.pdf 7/20/2016
AP27/19/2016N25558000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/079166s000ltr.pdf 5/17/2010
AP27/19/2016N46562000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079166Orig1s000ltr.pdf 7/20/2016




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