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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 213797

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NDA 213797 describes LEVOLEUCOVORIN CALCIUM, which is a drug marketed by Actavis Llc, Amneal, Hikma, Meitheal, Gland Pharma Ltd, Hainan Poly Pharm, Norvium Bioscience, Novast Labs, 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 213797

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

Medical Subject Heading (MeSH) Categories for 213797

Antidotes

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SOLUTION;INTRAVENOUS			Strength	EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
Approval Date:	Nov 2, 2021	TE:		RLD:	No

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