APPLICATION
ANDA089628
TYPE
ANDA
ORIGINAL APPROVAL
1997-04-17
LATEST ACTION
1998-09-15
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LEUCOVORIN CALCIUMDiscontinued
LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
1998-09-15Manufacturing (CMC) · Supplement 1AP
1998-05-06Labeling · Supplement 3AP
1998-02-24Labeling · Supplement 2AP
1997-04-17OriginalAP
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.