APPLICATION
ANDA204679
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-28
LATEST ACTION
2025-06-24
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ROCURONIUM BROMIDEPrescription
ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) · INJECTABLE · INJECTION
ROCURONIUM BROMIDEPrescription
ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2025-06-24Labeling · Supplement 8 · standardAP
2019-04-16Labeling · Supplement 4 · standardAP
2019-01-04Labeling · Supplement 1 · standardAP
2017-02-28UNKNOWN · Original · standardAP
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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