APPLICATION
NDA008107
TYPE
NDA
ORIGINAL APPROVAL
1952-06-20
LATEST ACTION
2003-12-17
ROUTE
INJECTION, ORAL, INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
INJECTABLE, FOR SOLUTION, SOLUTION
MARKETING STATUS
Discontinued
Products
LEUCOVORIN CALCIUM · ReferenceDiscontinued
LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LEUCOVORIN CALCIUM · ReferenceDiscontinued
LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LEUCOVORIN CALCIUM · ReferenceDiscontinued
LEUCOVORIN CALCIUM EQ 350MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LEUCOVORIN CALCIUMDiscontinued
LEUCOVORIN CALCIUM EQ 60MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · FOR SOLUTION · ORAL
LEUCOVORIN CALCIUM · ReferenceDiscontinued
LEUCOVORIN CALCIUM EQ 3MG BASE/ML (EQ 3MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
Approval history
1999-11-08Manufacturing (CMC) · Supplement 52 · priorityAP
1996-05-24Labeling · Supplement 50 · standardAP
1996-01-26Manufacturing (CMC) · Supplement 49 · priorityAP
1992-12-15Labeling · Supplement 48AP
1992-03-10Manufacturing (CMC) · Supplement 42 · priorityAP
1991-12-12Efficacy · Supplement 40AP
1990-09-11Manufacturing (CMC) · Supplement 46 · priorityAP
1989-08-23Manufacturing (CMC) · Supplement 43 · priorityAP
1989-04-05Manufacturing (CMC) · Supplement 38 · priorityAP
1988-08-31Efficacy · Supplement 39AP
1988-08-30Labeling · Supplement 35AP
1988-05-23Manufacturing (CMC) · Supplement 36 · priorityAP
1987-01-30Efficacy · Supplement 33AP
1987-01-30Labeling · Supplement 34AP
1987-01-30Efficacy · Supplement 32AP
1984-06-28Manufacturing (CMC) · Supplement 31 · priorityAP
1984-02-22Manufacturing (CMC) · Supplement 30 · priorityAP
1983-03-29Labeling · Supplement 29AP
1981-03-27Labeling · Supplement 27AP
1981-01-27Manufacturing (CMC) · Supplement 26 · priorityAP
1980-12-22Manufacturing (CMC) · Supplement 25 · priorityAP
1980-12-19Manufacturing (CMC) · Supplement 24 · priorityAP
1980-09-04Manufacturing (CMC) · Supplement 23 · priorityAP
1980-04-28Manufacturing (CMC) · Supplement 20 · priorityAP
1980-02-05Manufacturing (CMC) · Supplement 22 · priorityAP
1980-01-16Manufacturing (CMC) · Supplement 21 · priorityAP
1979-09-07Manufacturing (CMC) · Supplement 18 · priorityAP
1979-07-25Manufacturing (CMC) · Supplement 19 · priorityAP
1979-03-09Manufacturing (CMC) · Supplement 15 · priorityAP
1979-03-06Manufacturing (CMC) · Supplement 17 · priorityAP
1979-03-06Manufacturing (CMC) · Supplement 16 · priorityAP
1977-11-11Manufacturing (CMC) · Supplement 14 · priorityAP
1977-08-15Manufacturing (CMC) · Supplement 13 · priorityAP
1952-06-20Type 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.
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