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FDA ANDA · ANDA071199

LEUCOVORIN CALCIUM

Sponsor: BARR

APPLICATION
ANDA071199
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 25MG BASE · TABLET · ORAL

Approval history

2026-05-05Labeling · Supplement 34 · standardAP
2000-12-26Manufacturing (CMC) · Supplement 19AP
1999-12-21Manufacturing (CMC) · Supplement 18AP
1999-09-16Manufacturing (CMC) · Supplement 17AP
1999-05-20Manufacturing (CMC) · Supplement 16AP
1998-12-01Manufacturing (CMC) · Supplement 15AP
1998-09-08Manufacturing (CMC) · Supplement 14AP
1997-11-20Labeling · Supplement 13AP
1997-06-20Manufacturing (CMC) · Supplement 12AP
1997-04-07Manufacturing (CMC) · Supplement 11AP
1995-02-10Manufacturing (CMC) · Supplement 10AP
1994-12-23Manufacturing (CMC) · Supplement 9AP
1994-10-11Manufacturing (CMC) · Supplement 8AP
1992-07-16Labeling · Supplement 7AP
1992-04-03Manufacturing (CMC) · Supplement 6AP
1992-04-03Manufacturing (CMC) · Supplement 4AP
1991-02-22Manufacturing (CMC) · Supplement 2AP
1990-12-18Labeling · Supplement 3AP
1987-09-24OriginalAP
VIEW ON DRUGS@FDA ↗

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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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