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FDA ANDA · ANDA040056

LEUCOVORIN CALCIUM

Sponsor: HIKMA

APPLICATION
ANDA040056
TYPE
ANDA
ORIGINAL APPROVAL
1995-05-23
LATEST ACTION
2012-01-17
ROUTE
INTRAMUSCULAR, INTRAVENOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LEUCOVORIN CALCIUM PRESERVATIVE FREEPrescription
LEUCOVORIN CALCIUM EQ 200MG BASE/VIAL · INJECTABLE · INJECTION

Approval history

2012-01-17Labeling · Supplement 11 — Label ↗AP
2000-12-21Manufacturing (CMC) · Supplement 4AP
1998-08-03Labeling · Supplement 3AP
1998-02-24Labeling · Supplement 2AP
1996-05-31Labeling · Supplement 1AP
1995-05-23OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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