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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 203563

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NDA 203563 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 203563

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

Medical Subject Heading (MeSH) Categories for 203563

Antidotes

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date:	Mar 9, 2015	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
Approval Date:	Mar 9, 2015	TE:		RLD:	No

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