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FDA Drug Application 202278 by TEVA BRANDED PHARM

Application Number202278
Application Type New Drug Application
Sponsor ApplicantTEVA BRANDED PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP01/17/2013N34903000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/202278Orig1s000ltr.pdf 1/22/2013
AP01/17/2013N34926000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/202278s000lbl.pdf 1/22/2013
AP01/17/2013N37910000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202278Orig1s000TOC.cfm 11/25/2013
AP01/17/2013N37911000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/202278Orig1s000SumR.pdf 11/25/2013
AP03/21/2014SLR38880001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002ltr.pdf 3/25/2014
AP03/21/2014SLR38891001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf 3/25/2014
AP03/21/2014SLR38881002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202278Orig1s001,s002ltr.pdf 3/25/2014
AP03/21/2014SLR38892002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202278s001s002lbl.pdf 3/25/2014
AP03/16/2015SCM       
AP01/17/2014SCM       
AP08/24/2015SCM       
AP04/7/2015SCM       




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