Last Updated: September 28, 2026

Details for New Drug Application (NDA): 018459

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NDA 018459 describes LEUCOVORIN CALCIUM, which is a drug marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, Gland, Hainan Poly, Hikma, Meitheal, Pharmachemie, Pharmachemie Usa, Teva Parenteral, Teva Pharms Usa, Fresenius Kabi Usa, Ingenus Pharms Llc, Ani Pharms, Barr, Epic Pharma Llc, Leading, Par Pharm, Xanodyne Pharm, Am Regent, Mylan Labs Ltd, Sagent Pharms, and Sagent Pharms Inc, and is included in forty-nine NDAs. It is available from fourteen suppliers. Additional details are available on the LEUCOVORIN CALCIUM profile page.

The generic ingredient in LEUCOVORIN CALCIUM 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 018459

Tradename:	LEUCOVORIN CALCIUM
Applicant:	Xanodyne Pharm
Ingredient:	leucovorin calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 018459

Antidotes
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Jan 30, 1986	TE:		RLD:	No

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