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FDA ANDA · ANDA089384

LEUCOVORIN CALCIUM

Sponsor: HIKMA

APPLICATION
ANDA089384
TYPE
ANDA
ORIGINAL APPROVAL
1987-09-14
LATEST ACTION
2020-10-13
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LEUCOVORIN CALCIUMPrescription
LEUCOVORIN CALCIUM EQ 50MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2020-10-13Labeling · Supplement 31 · standardAP
2012-01-17Labeling · Supplement 22 — Label ↗AP
2001-05-30Manufacturing (CMC) · Supplement 14AP
2001-05-30Manufacturing (CMC) · Supplement 12AP
2001-05-30Manufacturing (CMC) · Supplement 13AP
2000-12-04Manufacturing (CMC) · Supplement 11AP
1998-08-03Labeling · Supplement 10AP
1998-02-24Labeling · Supplement 9AP
1996-05-31Labeling · Supplement 8AP
1995-09-25Manufacturing (CMC) · Supplement 7AP
1995-08-08Manufacturing (CMC) · Supplement 2AP
1994-03-21Manufacturing (CMC) · Supplement 6AP
1993-06-02Labeling · Supplement 5AP
1992-09-02Manufacturing (CMC) · Supplement 4AP
1992-09-02Manufacturing (CMC) · Supplement 1AP
1991-03-11Labeling · Supplement 3AP
1987-09-14OriginalAP
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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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