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FDA Drug Application 204061 by TEVA BRANDED PHARM

Application Number204061
Application Type New Drug Application
Sponsor ApplicantTEVA BRANDED PHARM
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
AP03/28/2013N35576000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/204061Orig1s000ltr.pdf 3/29/2013
AP03/28/2013N35612000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/204061s000lbl.pdf 4/1/2013
AP03/28/2013N35842000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204061_quartette_toc.cfm 4/25/2013
AP03/28/2013N35843000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/204061Orig1s000SumR.pdf 4/25/2013




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