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
AKYNZEO از شرکت HELSINN HLTHCARE
New Drug Application (NDA): 210493
Company: HELSINN HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AKYNZEO | FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE | EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL | POWDER;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| AKYNZEO | FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE | EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ 0.0125MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 04/19/2018 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210493s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/2021 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210493s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/210493Orig1s004ltr.pdf |
||
| 10/27/2020 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210493Orig1s003ltr.pdf |
||
| 05/27/2020 | SUPPL-2 | Manufacturing (CMC)-Facility |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/210493Orig1s002ltr.pdf |
||
| 02/24/2020 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/02/2021 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210493s004lbl.pdf | |
| 10/27/2020 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s003lbl.pdf | |
| 05/27/2020 | SUPPL-2 |
Manufacturing (CMC)-Facility |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210493Orig1s002lbl.pdf | |
| 04/19/2018 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210493s000lbl.pdf |
نظرات کاربران