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FDA Drug Application 077963 by TEVA PHARMS USA

Application Number077963
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
TA04/13/2007TA       
AP11/3/2008N       
AP21/3/2008N       
AP04/11/2012SLR32555010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077963s010lbl.pdf 4/30/2012
AP09/18/2014SLR40586016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf 9/24/2014
AP09/18/2014SLR40605016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf 9/25/2014




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