← FDA DRUG APPROVALS

FDA NDA · NDA215868

MIDAZOLAM IN 0.8% SODIUM CHLORIDE

Sponsor: EXELA PHARMA

APPLICATION
NDA215868
TYPE
NDA
ORIGINAL APPROVAL
2022-07-20
LATEST ACTION
2023-01-13
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

MIDAZOLAM IN 0.8% SODIUM CHLORIDE · ReferenceDiscontinued
MIDAZOLAM 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAVENOUS
MIDAZOLAM IN 0.8% SODIUM CHLORIDE · ReferenceDiscontinued
MIDAZOLAM 100MG/100ML (1MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-01-13Labeling · Supplement 1 · standard — Letter ↗AP
2022-07-20Type 5 - New Formulation or New Manufacturer · Original · standard — 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 →