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FDA Drug Application 022160 by TEVA PHARMS

Application Number022160
Application Type New Drug Application
Sponsor ApplicantTEVA PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA05/22/2009TA23558000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022160s000ltr.pdf 10/13/2009
AP18/7/2009N23558000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022160s000ltr.pdf 10/13/2009
TA05/22/2009TA25475000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022160_oxaliplatin_toc.cfm 5/6/2010
AP18/7/2009N25475000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022160_oxaliplatin_toc.cfm 5/6/2010
TA05/22/2009TA25476000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022160s000SumR.pdf 5/6/2010
AP18/7/2009N25476000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022160s000SumR.pdf 5/6/2010
AP08/10/2012SLR33430004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022160Orig1s004ltr.pdf 8/13/2012
AP08/10/2012SLR33453004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022160s004lbl.pdf 8/15/2012
AP011/20/2012SCM       
AP011/25/2013SLR37951008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022160Orig1s008ltr.pdf 11/27/2013
AP011/25/2013SLR37936009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022160s009lbl.pdf 11/26/2013
AP011/25/2013SLR37950009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/022160Orig1s009ltr.pdf 11/27/2013
AP04/20/2016SLR45721010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022160Orig1s010ltr.pdf 4/22/2016
AP04/20/2016SLR45781010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022160s010lbl.pdf 4/27/2016




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