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FDA Drug Application 202813 by TEVA BRANDED PHARM

Application Number202813
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
AP03/23/2012N32198000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202813s000ltr.pdf 3/27/2012
AP03/23/2012N32220000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202813s000lbl.pdf 3/27/2012
AP03/23/2012N36247000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202813_qnasl_toc.cfm 6/10/2013
AP03/23/2012N36248000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202813Orig1s000SumR.pdf 6/10/2013
AP08/29/2013SCM       
AP03/9/2015SCM       
AP03/19/2014SLR38855005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s005lbl.pdf 3/20/2014
AP03/19/2014SLR38859005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s005ltr.pdf 3/20/2014
AP07/10/2014SLR39848006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s006ltr.pdf 7/11/2014
AP012/17/2014SE841296007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s007,s009ltr.pdf 12/18/2014
AP012/17/2014SE841323007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf 12/19/2014
AP02/3/2015SCM       
AP012/17/2014SE841324009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/202813s007s009lbl.pdf 12/19/2014
AP012/17/2014SE841295009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/202813Orig1s007,s009ltr.pdf 12/18/2014
AP02/29/2016SCM       




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