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FDA Drug Application 022536 by FRESENIUS KABI USA

Application Number022536
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
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
AP03/17/2010N25074000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022536lbl.pdf 3/18/2010
AP03/17/2010N25083000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022536s000ltr.pdf 3/22/2010
AP03/17/2010N26083000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022536_indomethacin_toc.cfm 8/2/2010
AP03/17/2010N26084000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/022536s000SumR.pdf 8/2/2010
AP06/5/2015SCM       




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