APPLICATION
ANDA071198
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-24
LATEST ACTION
2026-05-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEUCOVORIN CALCIUMPrescription
LEUCOVORIN CALCIUM EQ 5MG BASE · TABLET · ORAL
Approval history
2026-05-05Labeling · Supplement 43 · standardAP
2000-12-26Manufacturing (CMC) · Supplement 30AP
2000-04-21Manufacturing (CMC) · Supplement 28AP
2000-04-21Manufacturing (CMC) · Supplement 29AP
1999-12-21Manufacturing (CMC) · Supplement 27AP
1999-09-16Manufacturing (CMC) · Supplement 26AP
1999-05-20Manufacturing (CMC) · Supplement 25AP
1998-12-01Manufacturing (CMC) · Supplement 24AP
1998-07-24Manufacturing (CMC) · Supplement 23AP
1997-11-10Labeling · Supplement 22AP
1997-06-20Manufacturing (CMC) · Supplement 21AP
1997-06-20Manufacturing (CMC) · Supplement 20AP
1997-04-07Manufacturing (CMC) · Supplement 19AP
1995-02-10Manufacturing (CMC) · Supplement 18AP
1994-12-23Manufacturing (CMC) · Supplement 17AP
1994-10-11Manufacturing (CMC) · Supplement 16AP
1992-07-16Labeling · Supplement 15AP
1992-04-03Manufacturing (CMC) · Supplement 14AP
1992-04-03Manufacturing (CMC) · Supplement 12AP
1991-02-23Manufacturing (CMC) · Supplement 8AP
1991-02-23Manufacturing (CMC) · Supplement 6AP
1991-02-23Manufacturing (CMC) · Supplement 9AP
1991-02-23Labeling · Supplement 7AP
1991-02-23Labeling · Supplement 10AP
1990-12-18Labeling · Supplement 11AP
1989-03-20Labeling · Supplement 4AP
1989-03-20Manufacturing (CMC) · Supplement 2AP
1989-03-20Manufacturing (CMC) · Supplement 5AP
1989-03-20Manufacturing (CMC) · Supplement 3AP
1987-09-24OriginalAP
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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