FDA ANDA · ANDA218200
LEUCOVORIN CALCIUM
Sponsor: GLAND
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APPLICATION
ANDA218200
TYPE
ANDA
ORIGINAL APPROVAL
2025-11-12
LATEST ACTION
2026-10-14
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription
Products
LEUCOVORIN CALCIUMPrescription
LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL · INJECTABLE · INJECTION
LEUCOVORIN CALCIUMPrescription
LEUCOVORIN CALCIUM EQ 500MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2026-10-14Manufacturing (CMC) · Supplement 1 · unknownAP
2025-11-12UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →