APPLICATION
NDA018459
TYPE
NDA
ORIGINAL APPROVAL
1980-02-08
LATEST ACTION
2001-10-09
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
LEUCOVORIN CALCIUMDiscontinued
LEUCOVORIN CALCIUM EQ 5MG BASE · TABLET · ORAL
Approval history
2001-10-09Manufacturing (CMC) · Supplement 16AP
1997-11-25Manufacturing (CMC) · Supplement 14AP
1996-06-24Labeling · Supplement 12AP
1991-11-21Labeling · Supplement 11AP
1989-07-26Labeling · Supplement 8AP
1988-11-05Manufacturing (CMC) · Supplement 1AP
1988-11-04Manufacturing (CMC) · Supplement 3AP
1988-11-04Labeling · Supplement 2AP
1987-03-30Labeling · Supplement 6AP
1987-03-05Manufacturing (CMC) · Supplement 5AP
1980-02-08OriginalAP
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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