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FDA NDA · NDA217472

ROCURONIUM

rocuronium bromide

Sponsor: FRESENIUS KABI USA

APPLICATION
NDA217472
TYPE
NDA
ORIGINAL APPROVAL
2025-06-09
LATEST ACTION
2026-07-15
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

ROCURONIUM BROMIDE · ReferencePrescription
ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) · SOLUTION · INTRAVENOUS
ROCURONIUM BROMIDE · ReferencePrescription
ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2026-07-15Labeling · Supplement 2 · standard — Label ↗AP
2025-06-09Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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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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