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FDA Drug Application 202231 by FRESENIUS KABI USA

Application Number202231
Application Type New Drug Application
Sponsor ApplicantFRESENIUS KABI USA
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/24/2011N29308000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/202231s000lbl.pdf 6/28/2011
AP06/24/2011N29379000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/202231s000ltr.pdf 7/5/2011
AP06/24/2011N32067000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202231_levothyroxine_toc.cfm 3/9/2012
AP06/24/2011N32068000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/202231Orig1s000Sum.pdf 3/9/2012
AP012/20/2012SLR34747003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/202231s003lbl.pdf 12/21/2012
AP012/20/2012SLR34760003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/202231Orig1s003ltr.pdf 12/26/2012
AP02/16/2013SCM       
AP011/26/2013SCM       
AP06/4/2014SCM       




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