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FDA ANDA · ANDA071962

LEUCOVORIN CALCIUM

Sponsor: XANODYNE PHARM

APPLICATION
ANDA071962
TYPE
ANDA
ORIGINAL APPROVAL
1987-11-19
LATEST ACTION
1993-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

LEUCOVORIN CALCIUMDiscontinued
LEUCOVORIN CALCIUM EQ 10MG BASE · TABLET · ORAL

Approval history

1993-04-28Manufacturing (CMC) · Supplement 10AP
1991-11-21Labeling · Supplement 9AP
1991-07-29Manufacturing (CMC) · Supplement 7AP
1991-07-29Manufacturing (CMC) · Supplement 8AP
1989-07-26Labeling · Supplement 5AP
1988-11-04Labeling · Supplement 3AP
1988-11-04Manufacturing (CMC) · Supplement 1AP
1988-11-04Manufacturing (CMC) · Supplement 2AP
1987-11-19OriginalAP
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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