Last Updated: November 8, 2026

Details for New Drug Application (NDA): 040347

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NDA 040347 describes LEUCOVORIN CALCIUM PRESERVATIVE FREE, which is a drug marketed by Am Regent, Fresenius Kabi Usa, Hikma, Mylan Labs Ltd, Sagent Pharms, Sagent Pharms Inc, Hospira, and Teva Parenteral, and is included in twelve NDAs. It is available from five suppliers. Additional details are available on the LEUCOVORIN CALCIUM PRESERVATIVE FREE profile page.

The generic ingredient in LEUCOVORIN CALCIUM PRESERVATIVE FREE is leucovorin calcium. There is one drug master file entry for this compound. Seventeen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for 040347

Tradename:	LEUCOVORIN CALCIUM PRESERVATIVE FREE
Applicant:	Hikma
Ingredient:	leucovorin calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 040347

Antidotes
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 300MG BASE/30ML (EQ 10MG BASE/ML)
Approval Date:	Apr 25, 2000	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)
Approval Date:	Apr 25, 2000	TE:		RLD:	No

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