AFREZZA از شرکت MANNKIND

اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است

AFREZZA از شرکت MANNKIND

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

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
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

Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022472Orig1s017ltr.pdf

09/29/2017 SUPPL-11 Supplement

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 Supplement

Label is not available on this site.

02/17/2016 SUPPL-9 Supplement

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022472s009lbl.pdf

06/24/2015 SUPPL-8 Supplement

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 Supplement

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 Supplement

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 Supplement

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s004lbl.pdf

04/17/2015 SUPPL-3 Supplement

Label (PDF)

https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s003lbl.pdf

04/20/2015 SUPPL-2 Supplement

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
10/25/2018 SUPPL-18

Labeling-Medication Guide

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022472s018lbl.pdf
10/25/2018 SUPPL-18

Labeling-Package Insert

Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022472s018lbl.pdf
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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