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FDA ANDA · ANDA040347

LEUCOVORIN CALCIUM PRESERVATIVE FREE

Sponsor: HIKMA

APPLICATION
ANDA040347
TYPE
ANDA
ORIGINAL APPROVAL
2000-04-25
LATEST ACTION
2012-01-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

LEUCOVORIN CALCIUM PRESERVATIVE FREEDiscontinued
LEUCOVORIN CALCIUM EQ 300MG BASE/30ML (EQ 10MG BASE/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS
LEUCOVORIN CALCIUM PRESERVATIVE FREEDiscontinued
LEUCOVORIN CALCIUM EQ 500MG BASE/50ML (EQ 10MG BASE/ML) · SOLUTION · INTRAMUSCULAR, INTRAVENOUS

Approval history

2012-01-17Labeling · Supplement 10LabelAP
2001-04-03Manufacturing (CMC) · Supplement 1AP
2000-04-25OriginalLabelAP
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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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