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
ALECENSA از شرکت HOFFMANN-LA ROCHE
New Drug Application (NDA): 208434
Company: HOFFMANN-LA ROCHE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALECENSA | ALECTINIB HYDROCHLORIDE | EQ 150MG 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 |
|---|---|---|---|---|---|---|---|
| 12/11/2015 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY; Orphan |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/29/2021 | SUPPL-10 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208434s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/208434Orig1s010ltr.pdf |
||
| 06/05/2018 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208434s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208434Orig1s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/208434Orig1s004ltr.pdf |
||
| 11/06/2017 | SUPPL-3 | Efficacy-New Indication |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208434s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/208434Orig1s003ltr.pdf |
||
| 11/04/2016 | SUPPL-1 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208434s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/208434Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 01/29/2021 | SUPPL-10 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/208434s010lbl.pdf | |
| 06/05/2018 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208434s004lbl.pdf | |
| 11/06/2017 | SUPPL-3 |
Efficacy-New Indication |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208434s003lbl.pdf | |
| 11/04/2016 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/208434s001lbl.pdf | |
| 12/11/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208434s000lbl.pdf |
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