← FDA DRUG APPROVALS

FDA ANDA · ANDA201044

ETOMIDATE

Sponsor: MYLAN LABS LTD

APPLICATION
ANDA201044
TYPE
ANDA
ORIGINAL APPROVAL
2017-02-07
LATEST ACTION
2018-03-07
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

ETOMIDATEPrescription
ETOMIDATE 2MG/ML · INJECTABLE · INJECTION

Approval history

2018-03-07Labeling · Supplement 1 · standardAP
2017-02-07Not Applicable · OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industryGMP disciplineFDA drug shortagesFDA 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 →