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FDA Drug Application 205208 by TEVA PHARMS USA

Application Number205208
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
AP010/11/2013N37431000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/205208Orig1s000ltr.pdf 10/16/2013
AP010/11/2013N37435000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205208s000lbl.pdf 10/17/2013
AP010/11/2013N37546000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM372058.pdf 10/24/2013
AP010/11/2013N38910000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205208Orig1s000TOC.cfm 3/26/2014
AP010/11/2013N38913000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/205208Orig1s000SumR.pdf 3/26/2014
AP07/18/2014SLR39999001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/205208Orig1s001ltr.pdf 7/25/2014
AP07/18/2014SLR40050001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205208Orig1s001lbl.pdf 7/29/2014




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