APPLICATION
ANDA075571
TYPE
ANDA
ORIGINAL APPROVAL
2000-08-22
LATEST ACTION
2004-06-18
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ENALAPRILATDiscontinued
ENALAPRILAT 1.25MG/ML · INJECTABLE · INJECTION
Approval history
2004-06-18Labeling · Supplement 2AP
2001-09-17Manufacturing (CMC) · Supplement 1AP
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
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.