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FDA Drug Application 022472 by MANNKIND

Application Number022472
Application Type New Drug Application
Sponsor ApplicantMANNKIND
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
AP06/27/2014N39708000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf 7/1/2014
AP06/27/2014N39711000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdf 7/1/2014
AP06/27/2014N39729000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=319 7/2/2014
AP06/27/2014N42951000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000TOC.cfm 5/29/2015
AP06/27/2014N42952000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000SumR.pdf 5/29/2015
AP04/20/2015SLR42593002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s002ltr.pdf 4/21/2015
AP04/20/2015SLR42601002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s002lbl.pdf 4/21/2015
AP04/20/2015SLR42901002   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM447695.pdf 5/27/2015
AP04/17/2015SCM42625003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s003lbl.pdf 4/22/2015
AP09/16/2015SCM43963004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s004lbl.pdf 9/23/2015
AP03/12/2015SLR42137005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s005ltr.pdf 3/13/2015
AP03/12/2015SLR42518005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472Orig1s005lbl.pdf 4/14/2015
AP06/24/2015SCM43115006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf 6/25/2015
AP06/24/2015SCM43362006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s006,s008ltr.pdf 7/14/2015
AP06/24/2015SLR43363008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s006,s008ltr.pdf 7/14/2015
AP06/24/2015SLR43116008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf 6/25/2015
AP02/17/2016SCM45196009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022472s009lbl.pdf 2/18/2016
AP04/7/2016SCM       




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