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
ADZENYS XR-ODT از شرکت NEOS THERAPS
New Drug Application (NDA): 204326
Company: NEOS THERAPS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADZENYS XR-ODT | AMPHETAMINE | EQ 3.1MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADZENYS XR-ODT | AMPHETAMINE | EQ 6.3MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADZENYS XR-ODT | AMPHETAMINE | EQ 9.4MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADZENYS XR-ODT | AMPHETAMINE | EQ 12.5MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADZENYS XR-ODT | AMPHETAMINE | EQ 15.7MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADZENYS XR-ODT | AMPHETAMINE | EQ 18.8MG BASE | TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 01/27/2016 | ORIG-1 | Approval |
Type 5 – New Formulation or New Manufacturer |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/04/2017 | SUPPL-2 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/204326Orig1s002ltr.pdf |
||
| 11/18/2016 | SUPPL-1 | Labeling-Container/Carton Labels |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204326Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/04/2017 | SUPPL-2 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/204326s002lbl.pdf | |
| 11/18/2016 | SUPPL-1 |
Labeling-Container/Carton Labels |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s001lbl.pdf | |
| 01/27/2016 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204326s000lbl.pdf |
نظرات کاربران