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FDA ANDA · ANDA206263

LEVOLEUCOVORIN

Sponsor: HIKMA

APPLICATION
ANDA206263
TYPE
ANDA
ORIGINAL APPROVAL
2016-06-16
LATEST ACTION
2022-12-16
ROUTE
INTRAVENOUS
DOSAGE FORM
POWDER
MARKETING STATUS
Discontinued

Products

LEVOLEUCOVORIN CALCIUMDiscontinued
LEVOLEUCOVORIN CALCIUM EQ 50MG BASE/VIAL · POWDER · INTRAVENOUS

Approval history

2022-12-16Labeling · Supplement 2 · standardAP
2022-12-16Labeling · Supplement 3 · standardAP
2016-06-16UNKNOWN · Original · standard — Label ↗AP
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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