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FDA Drug Application 078392 by TEVA PHARMS USA

Application Number078392
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
TA010/18/2007TA       
AP112/31/2007N       
AP04/13/2012SLR32556011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/078392s011lbl.pdf 4/30/2012
AP09/18/2014SLR40588017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf 9/24/2014
AP09/18/2014SLR40607017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf 9/25/2014




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