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
ADHANSIA XR از شرکت PURDUE PHARMA LP
New Drug Application (NDA): 212038
Company: PURDUE PHARMA LP
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 25MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 35MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 45MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 55MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 70MG | CAPSULE, EXTENDED RELEASE;ORAL | Prescription |
None |
Yes | No |
| ADHANSIA XR | METHYLPHENIDATE HYDROCHLORIDE | 85MG | CAPSULE, 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 |
|---|---|---|---|---|---|---|---|
| 02/27/2019 | ORIG-1 | Approval |
Type 3 – New Dosage Form |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038Orig1s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 06/25/2021 | SUPPL-5 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/212038Orig1s005ltr.pdf |
||
| 06/28/2021 | SUPPL-2 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s002lbl.pdf |
||
| 07/03/2019 | SUPPL-1 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/212038Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/28/2021 | SUPPL-2 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s002lbl.pdf | |
| 06/25/2021 | SUPPL-5 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/212038s005lbl.pdf | |
| 07/03/2019 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038s001lbl.pdf | |
| 02/27/2019 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/212038Orig1s000lbl.pdf |
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