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FDA ANDA · ANDA210892

LEVOLEUCOVORIN

Sponsor: GLAND

APPLICATION
ANDA210892
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-14
LATEST ACTION
2023-07-12
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

LEVOLEUCOVORIN CALCIUMPrescription
LEVOLEUCOVORIN CALCIUM EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS
LEVOLEUCOVORIN CALCIUMPrescription
LEVOLEUCOVORIN CALCIUM EQ 250MG BASE/25ML (EQ 10MG BASE/ML) · SOLUTION · INTRAVENOUS

Approval history

2023-07-12Labeling · Supplement 3 · standardAP
2023-07-12Labeling · Supplement 1 · standardAP
2018-09-14UNKNOWN · Original · standardLetterAP
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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