APPLICATION
NDA019879
TYPE
NDA
ORIGINAL APPROVAL
1990-11-28
LATEST ACTION
2002-01-03
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
ORNIDYLDiscontinued
EFLORNITHINE HYDROCHLORIDE 200MG/ML · INJECTABLE · INJECTION
Approval history
2002-01-03Manufacturing (CMC) · Supplement 2 · priorityAP
1995-04-17Manufacturing (CMC) · Supplement 1 · priorityAP
1990-11-28Type 1 - New Molecular Entity · Original · priorityAP
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.