APPLICATION
ANDA091458
TYPE
ANDA
ORIGINAL APPROVAL
2010-07-28
LATEST ACTION
2020-06-25
ROUTE
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
2020-06-25Labeling · Supplement 13 · standardAP
2018-07-26Labeling · Supplement 11 · standardAP
2015-10-16Labeling · Supplement 4 · standardAP
2012-10-16Labeling · Supplement 3 · standardAP
2011-09-27Labeling · Supplement 1AP
2010-07-28OriginalAP
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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