APPLICATION
ANDA078519
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-26
LATEST ACTION
2020-08-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
ROCURONIUM BROMIDEPrescription
ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) · INJECTABLE · INJECTION
ROCURONIUM BROMIDEPrescription
ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2020-08-07Labeling · Supplement 16 · standardAP
2018-07-26Labeling · Supplement 15 · standardAP
2018-07-19Labeling · Supplement 13 · standardAP
2013-06-13Labeling · Supplement 11 · standardAP
2011-05-24Labeling · Supplement 5AP
2010-06-15Labeling · Supplement 4AP
2010-01-12Labeling · Supplement 3AP
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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