NDA 22225, held by Msd Sub Merck. Sugammadex Sodium.
As of Nov 13, 2026, NDA 22225 (Bridion), held by Msd Sub Merck, was first approved by FDA on Dec 15, 2015, with 7 approved supplements and 0 published complete response letters.
BRIDION is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adult and pediatric patients undergoing surgery.
| Dec 12, 2024 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Jun 25, 2021 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jan 22, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2020 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Dec 15, 2015 | Original applicationNew molecular entity · Priority review | Approved |
| BridionEQ 500MG BASE/5ML (EQ 100MG BASE/ML) · solution;intravenous | Sugammadex Sodium | RxReference drug |
| BridionEQ 200MG BASE/2ML (EQ 100MG BASE/ML) · solution;intravenous | Sugammadex Sodium | RxReference drug |
| Dec 12, 2024 | Supplement 14Efficacy (new indication or use) · Priority review | Approved | |
| Nov 17, 2022 | Supplement 12Labeling · Standard review | Approved | |
| Jun 25, 2021 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Jan 22, 2021 | Supplement 9Labeling · Standard review | Approved | |
| Jan 22, 2021 | Supplement 7Efficacy (new indication or use) · Standard review | Approved | |
| Jun 9, 2020 | Supplement 6Efficacy (new indication or use) · Standard review | Approved | |
| Oct 24, 2016 | Supplement 1Labeling · Standard review | Approved | |
| Dec 15, 2015 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
