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Last Updated: December 14, 2025

Details for New Drug Application (NDA): 089384

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NDA 089384 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, Novast Labs, 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 thirteen suppliers. Additional details are available on the LEUCOVORIN CALCIUM profile page.

The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There are nine drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for 089384

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

Pharmacology for NDA: 089384

Medical Subject Heading (MeSH) Categories for 089384

Antidotes
Vitamin B Complex

Suppliers and Packaging for NDA: 089384

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEUCOVORIN CALCIUM	leucovorin calcium	INJECTABLE;INJECTION	089384	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9555	0143-9555-01	1 VIAL in 1 BOX (0143-9555-01) / 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	Sep 14, 1987	TE:	AP	RLD:	No

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