← FDA DRUG APPROVALS

FDA NDA · NDA022225

BRIDION

sugammadex

Sponsor: MSD SUB MERCK

APPLICATION
NDA022225
TYPE
NDA
ORIGINAL APPROVAL
2015-12-15
LATEST ACTION
2024-12-12
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

BRIDION · ReferencePrescription
SUGAMMADEX SODIUM EQ 500MG BASE/5ML (EQ 100MG BASE/ML) · SOLUTION · INTRAVENOUS
BRIDION · ReferencePrescription
SUGAMMADEX SODIUM EQ 200MG BASE/2ML (EQ 100MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2024-12-12Efficacy · Supplement 14 · priority — Letter ↗AP
2022-11-17Labeling · Supplement 12 · standard — Letter ↗AP
2021-06-25Efficacy · Supplement 8 · standard — Letter ↗AP
2021-01-22Labeling · Supplement 9 · standard — Letter ↗AP
2021-01-22Efficacy · Supplement 7 · standard — Letter ↗AP
2020-06-09Efficacy · Supplement 6 · standard — Letter ↗AP
2016-10-24Labeling · Supplement 1 · standard — Letter ↗AP
2015-12-15Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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