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Last Updated: November 22, 2024

Details for New Drug Application (NDA): 207548

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NDA 207548 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 207548

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

Pharmacology for NDA: 207548

Medical Subject Heading (MeSH) Categories for 207548

Antidotes

Suppliers and Packaging for NDA: 207548

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	207548	ANDA	Amneal Pharmaceuticals LLC	70121-1572	70121-1572-1	1 VIAL in 1 CARTON (70121-1572-1) / 17.5 mL in 1 VIAL

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:	Sep 8, 2017	TE:	AP	RLD:	No

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