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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 040338

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NDA 040338 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 are nine drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for 040338

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

Medical Subject Heading (MeSH) Categories for 040338

Antidotes
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	Jan 31, 2001	TE:		RLD:	No

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