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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022472lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 10/25/2018 | SUPPL-18 | Supplement |
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. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022472Orig1s017ltr.pdf |
|
| 09/29/2017 | SUPPL-11 | Supplement |
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 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022472s009lbl.pdf |
||
| 06/24/2015 | SUPPL-8 | Supplement |
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 |
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 |
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 |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s004lbl.pdf |
||
| 04/17/2015 | SUPPL-3 | Supplement |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022472s003lbl.pdf |
||
| 04/20/2015 | SUPPL-2 | Supplement |
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 |
نظرات کاربران