APPLICATION
ANDA072736
TYPE
ANDA
ORIGINAL APPROVAL
1993-02-22
LATEST ACTION
2026-05-05
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
LEUCOVORIN CALCIUMPrescription
LEUCOVORIN CALCIUM EQ 25MG BASE · TABLET · ORAL
Approval history
2026-05-05Labeling · Supplement 13 · standardAP
2001-11-07Manufacturing (CMC) · Supplement 7AP
2001-10-22Manufacturing (CMC) · Supplement 6AP
1997-11-07Labeling · Supplement 5AP
1996-08-28Manufacturing (CMC) · Supplement 4AP
1994-11-04Labeling · Supplement 2AP
1994-11-04Manufacturing (CMC) · Supplement 3AP
1994-11-04Manufacturing (CMC) · Supplement 1AP
1993-02-22OriginalAP
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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