Drugs@FDA: FDA-Approved Drugs

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Biologic License Application (BLA): 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 No No
AFREZZA INSULIN RECOMBINANT HUMAN 8 UNITS/INH POWDER;INHALATION Prescription None No No
AFREZZA INSULIN RECOMBINANT HUMAN 12 UNITS/INH POWDER;INHALATION Prescription None No 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 N/A Label (PDF)
Letter (PDF)
Review
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
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/25/2018 SUPPL-18 Supplement Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022472s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022472Orig1s018ltr.pdf
04/24/2018 SUPPL-17 Supplement

Label is not available on this site.

09/29/2017 SUPPL-11 Supplement

Label is not available on this site.

04/07/2016 SUPPL-10 Supplement

Label is not available on this site.

02/17/2016 SUPPL-9 Supplement

Label is not available on this site.

06/24/2015 SUPPL-8 Supplement

Label is not available on this site.

06/24/2015 SUPPL-6 Supplement

Label is not available on this site.

03/12/2015 SUPPL-5 Supplement

Label is not available on this site.

09/16/2015 SUPPL-4 Supplement

Label is not available on this site.

04/17/2015 SUPPL-3 Supplement

Label is not available on this site.

04/20/2015 SUPPL-2 Supplement

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/25/2018 SUPPL-18 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022472s018lbl.pdf
10/25/2018 SUPPL-18 Labeling-Medication Guide Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022472s018lbl.pdf
06/27/2014 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf

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