← FDA DRUG APPROVALS

FDA ANDA · ANDA075458

ENALAPRILAT

Sponsor: HOSPIRA

APPLICATION
ANDA075458
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-22
LATEST ACTION
2017-09-05
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ENALAPRILATDiscontinued
ENALAPRILAT 1.25MG/ML · INJECTABLE · INJECTION

Approval history

2017-09-05Labeling · Supplement 9 · standardAP
2010-04-28Labeling · Supplement 7LabelAP
2003-06-13Labeling · Supplement 3AP
2000-08-22OriginalLetterAP
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 →