← FDA DRUG APPROVALS

FDA ANDA · ANDA075936

MILRINONE LACTATE

Sponsor: FRESENIUS KABI USA

APPLICATION
ANDA075936
TYPE
ANDA
ORIGINAL APPROVAL
2002-05-28
LATEST ACTION
2007-02-08
ROUTE
INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

MILRINONE LACTATEPrescription
MILRINONE LACTATE EQ 1MG BASE/ML · INJECTABLE · INJECTION

Approval history

2007-02-08Labeling · Supplement 2AP
2002-05-28OriginalLetterAP
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 →