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FDA Drug Application 022485 by SANDOZ

Application Number022485
Application Type New Drug Application
Sponsor ApplicantSANDOZ
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
TA01/13/2011TA27539000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000ltr.pdf 1/19/2011
AP15/9/2011N27539000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000ltr.pdf 1/19/2011
TA01/13/2011TA28754000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022485lbl.pdf 5/9/2011
AP15/9/2011N28754000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022485lbl.pdf 5/9/2011
TA01/13/2011TA28793000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000(1)ltr.pdf 5/12/2011
AP15/9/2011N28793000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022485s000(1)ltr.pdf 5/12/2011
TA01/13/2011TA31341000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485_argatroban_toc.cfm 1/5/2012
AP15/9/2011N31341000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485_argatroban_toc.cfm 1/5/2012
TA01/13/2011TA31342000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485Orig1s000SumR.pdf 1/5/2012
AP15/9/2011N31342000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/022485Orig1s000SumR.pdf 1/5/2012
AP09/11/2014SCM       
AP012/1/2015SCM       
AP09/19/2016SCM       
AP09/19/2016SCM       
AP05/25/2016SLR46178009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022485Orig1s009ltr.pdf 5/27/2016
AP05/25/2016SLR46211009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022485s009lbl.pdf 6/1/2016




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