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
BRIDION از شرکت ORGANON SUB MERCK
New Drug Application (NDA): 022225
Company: ORGANON SUB MERCK
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRIDION | SUGAMMADEX SODIUM | EQ 500MG BASE/5ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | Yes |
| BRIDION | SUGAMMADEX SODIUM | EQ 200MG BASE/2ML (EQ 100MG BASE/ML) | SOLUTION;INTRAVENOUS | Prescription |
None |
Yes | No |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/15/2015 | ORIG-1 | Approval |
Type 1 – New Molecular Entity |
PRIORITY |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022225lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/22/2021 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022225Orig1s007, s009ltr.pdf |
||
| 06/25/2021 | SUPPL-8 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022225Orig1s008ltr.pdf |
||
| 01/22/2021 | SUPPL-7 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/022225Orig1s007, s009ltr.pdf |
||
| 06/09/2020 | SUPPL-6 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022225s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/022225Orig1s006ltr.pdf |
||
| 10/24/2016 | SUPPL-1 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022225s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/022225Orig1s001ltr.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 06/25/2021 | SUPPL-8 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s008lbl.pdf | |
| 01/22/2021 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf | |
| 01/22/2021 | SUPPL-7 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/022225s007s009lbl.pdf | |
| 06/09/2020 | SUPPL-6 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/022225s006lbl.pdf | |
| 10/24/2016 | SUPPL-1 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/022225s001lbl.pdf | |
| 12/15/2015 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022225lbl.pdf |
نظرات کاربران