Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022472
Company: MANNKIND
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
AFREZZA INSULIN RECOMBINANT HUMAN 4 UNITS/INH POWDER;INHALATION Prescription None Yes No
AFREZZA INSULIN RECOMBINANT HUMAN 8 UNITS/INH POWDER;INHALATION Prescription None Yes Yes
AFREZZA INSULIN RECOMBINANT HUMAN 12 UNITS/INH POWDER;INHALATION Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
06/27/2014 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/022472Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/022472Orig1s000SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/29/2017 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022472Orig1s011ltr.pdf
04/07/2016 SUPPL-10 Manufacturing (CMC)

Label is not available on this site.

02/17/2016 SUPPL-9 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022472s009lbl.pdf
06/24/2015 SUPPL-8 Labeling-Medication Guide, Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s006,s008ltr.pdf
06/24/2015 SUPPL-6 Manufacturing (CMC) Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s006,s008ltr.pdf
03/12/2015 SUPPL-5 Labeling-Container/Carton Labels Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472Orig1s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s005ltr.pdf
09/16/2015 SUPPL-4 Labeling-Patient Package Insert Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s004lbl.pdf
04/17/2015 SUPPL-3 Manufacturing (CMC) Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s003lbl.pdf
04/20/2015 SUPPL-2 REMS-Modified Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022472Orig1s002ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/29/2017 SUPPL-11 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022472s011lbl.pdf
02/17/2016 SUPPL-9 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022472s009lbl.pdf
09/16/2015 SUPPL-4 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s004lbl.pdf
06/24/2015 SUPPL-8 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf
06/24/2015 SUPPL-8 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf
06/24/2015 SUPPL-6 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s006s008lbl.pdf
04/20/2015 SUPPL-2 REMS-Modified Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s002lbl.pdf
04/17/2015 SUPPL-3 Manufacturing (CMC) Label (PDF) This supplement type does not usually require new labeling. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s003lbl.pdf
03/12/2015 SUPPL-5 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472Orig1s005lbl.pdf
06/27/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf

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