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FDA Drug Application 206769 by TEVA PHARMS USA

Application Number206769
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
AP012/15/2014N41264000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/206769s000lbl.pdf 12/16/2014
AP012/15/2014N41277000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/206769Orig1s000ltr.pdf 12/17/2014
AP012/15/2014N41698000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206769Orig1s000TOC.cfm 1/27/2015
AP012/15/2014N41699000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/206769Orig1s000SumR.pdf 1/27/2015
AP05/25/2016SLR46173002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206769Orig1s002ltr.pdf 5/27/2016
AP05/25/2016SLR46215002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/206769s002lbl.pdf 6/1/2016




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