← FDA DRUG APPROVALS

FDA ANDA · ANDA075549

VECURONIUM BROMIDE

Sponsor: HIKMA

APPLICATION
ANDA075549
TYPE
ANDA
ORIGINAL APPROVAL
2000-06-13
LATEST ACTION
2018-07-26
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

VECURONIUM BROMIDEPrescription
VECURONIUM BROMIDE 10MG/VIAL · INJECTABLE · INJECTION
VECURONIUM BROMIDEPrescription
VECURONIUM BROMIDE 20MG/VIAL · INJECTABLE · INJECTION

Approval history

2018-07-26Labeling · Supplement 13 · standard — Label ↗AP
2010-11-23Labeling · Supplement 9 — Label ↗AP
2007-03-01Labeling · Supplement 7AP
2001-02-26Labeling · Supplement 1AP
2000-06-13Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →