← FDA DRUG APPROVALS

FDA ANDA · ANDA208878

MIDAZOLAM HYDROCHLORIDE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA208878
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-28
LATEST ACTION
2019-11-13
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

MIDAZOLAM HYDROCHLORIDEDiscontinued
MIDAZOLAM HYDROCHLORIDE EQ 5MG BASE/ML · INJECTABLE · INJECTION

Approval history

2019-11-13Labeling · Supplement 1 · standardAP
2017-03-28UNKNOWN · Original · standardLabelAP
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 →