Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 022225
Company: ORGANON SUB MERCK
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 |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/17/2022 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/022225Orig1s012lbl.pdf | |
| 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 |