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FDA Drug Application 022453 by TEVA PHARMS USA

Application Number022453
Application Type New Drug Application
Sponsor ApplicantTEVA PHARMS USA
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
AP012/20/2012N34744000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022453s000lbl.pdf 12/21/2012
AP012/20/2012N34755000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022453Orig1s000ltr.pdf 12/26/2012
AP012/20/2012N36614000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453_topotecan_toc.cfm 7/26/2013
AP012/20/2012N36615000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022453Orig1s000SumR.pdf 7/26/2013
AP010/3/2013SCM       
AP02/28/2014SLR38645002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022453s002lbl.pdf 3/4/2014
AP02/28/2014SLR38662002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022453Orig1s002ltr.pdf 3/5/2014
AP09/23/2014SCM       
AP02/23/2015SCM       
AP13/30/2015SCM       
AP03/30/2015SCM       
AP01/29/2016SLR45057007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022453Orig1s007ltr.pdf 1/29/2016
AP01/29/2016SLR45275007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022453s007lbl.pdf 2/25/2016
AP012/21/2015SCM       




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