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): 205718
Company: HELSINN HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AKYNZEO | NETUPITANT; PALONOSETRON HYDROCHLORIDE | 300MG;EQ 0.5MG BASE | CAPSULE;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/10/2014 | ORIG-1 | Approval |
Type 1 – New Molecular Entity and Type 4 – New Combination |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/02/2021 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205718s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/205718Orig1s009ltr.pdf |
||
| 12/28/2016 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2016 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/20/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/13/2015 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/27/2015 | SUPPL-3 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718Orig1s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/205718Orig1s003ltr.pdf |
||
| 04/29/2015 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf |
||
| 02/16/2015 | SUPPL-1 | Manufacturing (CMC) |
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-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/205718s009lbl.pdf | |
| 04/29/2015 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718s002lbl.pdf | |
| 04/27/2015 | SUPPL-3 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/205718Orig1s003lbl.pdf | |
| 10/10/2014 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/205718s000lbl.pdf |
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