← FDA DRUG APPROVALS

FDA ANDA · ANDA209666

MILRINONE LACTATE

milrinone lactate in 5% dextrose

Sponsor: EUGIA PHARMA

APPLICATION
ANDA209666
TYPE
ANDA
ORIGINAL APPROVAL
2020-09-03
LATEST ACTION
2020-09-03
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MILRINONE LACTATE IN DEXTROSE 5%Prescription
MILRINONE LACTATE EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) · INJECTABLE · INJECTION
MILRINONE LACTATE IN DEXTROSE 5%Prescription
MILRINONE LACTATE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) · INJECTABLE · INJECTION

Approval history

2020-09-03UNKNOWN · Original · standardAP
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 →