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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 089628

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NDA 089628 describes LEUCOVORIN CALCIUM, which is a drug marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, 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-eight NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for 089628

Tradename:	LEUCOVORIN CALCIUM
Applicant:	Pharmachemie Usa
Ingredient:	leucovorin calcium
Patents:	0

Medical Subject Heading (MeSH) Categories for 089628

Antidotes
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	Apr 17, 1997	TE:		RLD:	No

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