Details for New Drug Application (NDA): 211002

NDA 211002 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 211002

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

Pharmacology for NDA: 211002

Medical Subject Heading (MeSH) Categories for 211002

Antidotes

Suppliers and Packaging for NDA: 211002

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	211002	ANDA	Meitheal Pharmaceuticals Inc.	71288-105	71288-105-18	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-18) / 17.5 mL in 1 VIAL, SINGLE-DOSE
LEVOLEUCOVORIN CALCIUM	levoleucovorin calcium	SOLUTION;INTRAVENOUS	211002	ANDA	Meitheal Pharmaceuticals Inc.	71288-105	71288-105-25	1 VIAL, SINGLE-DOSE in 1 CARTON (71288-105-25) / 25 mL in 1 VIAL, SINGLE-DOSE

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:	Aug 16, 2019	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:	Aug 16, 2019	TE:		RLD:	No

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