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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 075327

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NDA 075327 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 075327

Tradename:	LEUCOVORIN CALCIUM
Applicant:	Ani Pharms
Ingredient:	leucovorin calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 075327

Antidotes
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 15MG BASE
Approval Date:	Mar 24, 1999	TE:		RLD:	No

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