APPLICATION
ANDA081277
TYPE
ANDA
ORIGINAL APPROVAL
1993-09-28
LATEST ACTION
2013-04-29
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LEUCOVORIN CALCIUMDiscontinued
LEUCOVORIN CALCIUM EQ 100MG BASE/VIAL · INJECTABLE · INJECTION
Approval history
2013-04-29Labeling · Supplement 20 · standardAP
1998-12-16Labeling · Supplement 6AP
1998-04-28Labeling · Supplement 5AP
1997-11-10Labeling · Supplement 3AP
1997-10-30Manufacturing (CMC) · Supplement 4AP
1996-05-20Labeling · Supplement 2AP
1994-07-05Manufacturing (CMC) · Supplement 1AP
1993-09-28OriginalAP
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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