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FDA Drug Application 125553 by SANDOZ INC

Application Number125553
Application Type Biologic License Application
Sponsor ApplicantSANDOZ INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/6/2015N42035000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/125553lbl.pdf 3/6/2015
AP03/6/2015N42036000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/125553Orig1s000ltr.pdf 3/6/2015
AP03/6/2015N42578000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000TOC.cfm 4/20/2015
AP03/6/2015N42579000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/125553Orig1s000SumR.pdf 4/20/2015
AP03/3/2016SLR45373001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/125553Orig1s001ltr.pdf 3/4/2016
AP03/3/2016SLR45378001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125553s001lbl.pdf 3/4/2016




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