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Setid 49be5b16 Dab5 4a95 B202 Bfb13d730d83 Applno 20140 Form Solution Intravenous Dosage Eq 250mg Base 25ml Eq 10mg Base Ml - Drug Product Composition: Levoleucovorin Calcium

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$ API Ref.Price (USD/KG) : 6,104Xls

USFDA APPLICATION NUMBER - 20140 / DOSAGE - SOLUTION;INTRAVENOUS - EQ 250MG BASE/25ML (EQ 10MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LEVOLEUCOVORIN CALCIUM(UNII: 778XL6VBS8)
(LEVOLEUCOVORIN - UNII:990S25980Y)
LEVOLEUCOVORIN10mg in 1 | 50mg in 5

Inactive Ingredients

Ingredient Name
Spectrum Pharmaceuticals, Inc.
HYDROCHLORIC ACID(QTT17582CB)
MANNITOL(3OWL53L36A)
SODIUM CHLORIDE(451W47IQ8X)
SODIUM HYDROXIDE(55X04QC32I)
WATER(059QF0KO0R)