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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 210917

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NDA 210917 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 fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for 210917

Tradename:	LEUCOVORIN CALCIUM
Applicant:	Novast Labs
Ingredient:	leucovorin calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 210917

Antidotes
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAMUSCULAR, INTRAVENOUS			Strength	EQ 500MG BASE/50ML (EQ 10MG BASE/ML)
Approval Date:	Nov 23, 2018	TE:		RLD:	No

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