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FDA Drug Application 201743 by SANDOZ

Application Number201743
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
TA02/10/2011TA27835000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201743s000ltr.pdf 2/14/2011
TA02/10/2011TA28759000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201743lbl.pdf 5/9/2011
TA02/10/2011TA28792000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201743s000(1)ltr.pdf 5/12/2011
TA02/10/2011TA31344000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201743_argatroban_toc.cfm 1/5/2012
TA02/10/2011TA31346000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201743Orig1s000SumR.pdf 1/5/2012
AP15/9/2011N27835000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201743s000ltr.pdf 2/14/2011
AP15/9/2011N28759000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/201743lbl.pdf 5/9/2011
AP15/9/2011N28792000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/201743s000(1)ltr.pdf 5/12/2011
AP15/9/2011N31344000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201743_argatroban_toc.cfm 1/5/2012
AP15/9/2011N31346000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/201743Orig1s000SumR.pdf 1/5/2012
AP05/25/2016SLR46176001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/201743Orig1s001ltr.pdf 5/27/2016
AP05/25/2016SLR46210001   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/201743s001lbl.pdf 6/1/2016




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