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FDA Drug Application 200199 by SANDOZ INC

Application Number200199
Application Type New Drug Application
Sponsor ApplicantSANDOZ INC
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
AP02/25/2011N28008000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200199s000ltr.pdf 3/2/2011
AP02/25/2011N28055000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200199s000lbl.pdf 3/4/2011
AP02/25/2011N29964000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199_topotecan_toc.cfm 9/9/2011
AP02/25/2011N29965000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200199Orig1s000SumR.pdf 9/9/2011
AP02/28/2014SLR38644003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/200199s003lbl.pdf 3/4/2014
AP02/28/2014SLR38664003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/200199Orig1s003ltr.pdf 3/5/2014




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