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FDA Drug Application 079246 by TEVA PHARMS USA

Application Number079246
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
AP09/29/2016N47273000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079246Orig1s000ltr.pdf 10/4/2016
AP17/17/2014TA47273000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/079246Orig1s000ltr.pdf 10/4/2016
AP09/29/2016N47292000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/079246Orig1s000TAltr.pdf 10/6/2016
AP17/17/2014TA47292000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/079246Orig1s000TAltr.pdf 10/6/2016
AP09/29/2016N47301000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/079246s000lbl.pdf 10/6/2016
AP17/17/2014TA47301000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/079246s000lbl.pdf 10/6/2016




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