Last Updated: September 24, 2026

Details for New Drug Application (NDA): 081278

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NDA 081278 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 081278

Tradename:	LEUCOVORIN CALCIUM
Applicant:	Teva Parenteral
Ingredient:	leucovorin calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 081278

Antidotes
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	Sep 28, 1993	TE:		RLD:	No

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