APPLICATION
ANDA078717
TYPE
ANDA
ORIGINAL APPROVAL
2008-11-26
LATEST ACTION
2019-04-16
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ROCURONIUM BROMIDEDiscontinued
ROCURONIUM BROMIDE 50MG/5ML (10MG/ML) · INJECTABLE · INJECTION
ROCURONIUM BROMIDEDiscontinued
ROCURONIUM BROMIDE 100MG/10ML (10MG/ML) · INJECTABLE · INJECTION
Approval history
2019-04-16Labeling · Supplement 23 · standardAP
2018-07-26Labeling · Supplement 21 · standardAP
2015-10-26Labeling · Supplement 17 · standardAP
2012-07-17Labeling · Supplement 11 · standardAP
2012-01-31Labeling · Supplement 10AP
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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