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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 211003

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NDA 211003 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, Amneal, Hikma, Meitheal, Gland, Hainan Poly Pharm, Novast Labs, Pharmobedient, Praxgen, and Sandoz, and is included in thirteen NDAs. It is available from seven suppliers. Additional details are available on the LEVOLEUCOVORIN CALCIUM profile page.

The generic ingredient in LEVOLEUCOVORIN CALCIUM is levoleucovorin calcium. There is one drug master file entry for this compound. Seven suppliers are listed for this compound. Additional details are available on the levoleucovorin calcium profile page.

Summary for 211003

Tradename:	LEVOLEUCOVORIN CALCIUM
Applicant:	Meitheal
Ingredient:	levoleucovorin calcium
Patents:	0

Pharmacology for NDA: 211003

Medical Subject Heading (MeSH) Categories for 211003

Antidotes

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	POWDER;INTRAVENOUS			Strength	EQ 50MG BASE/VIAL
Approval Date:	Aug 22, 2019	TE:		RLD:	No

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