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FDA Drug Application 077297 by TEVA PHARMS USA

Application Number077297
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
TA08/16/2005TA12637000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077297TA_ltr.pdf 8/19/2005
TA11/8/2008TA12637000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077297TA_ltr.pdf 8/19/2005
AP26/30/2008N12637000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/077297TA_ltr.pdf 8/19/2005
AP04/13/2012SLR32554010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/077297s010lbl.pdf 4/30/2012
AP04/13/2012SLR46726010   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/077297Orig1s010.pdf 8/4/2016
AP09/18/2014SLR40587016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/077963Orig1s016,077297Orig1s016,078392Orig1s017ltr.pdf 9/24/2014
AP09/18/2014SLR40606016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/077963Orig1s016, 077297Orig1s016, 078392Orig1s017lbl.pdf 9/25/2014




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