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Generated: June 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200753

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NDA 200753 describes LEUCOVORIN CALCIUM PRESERVATIVE FREE, which is a drug marketed by Fresenius Kabi Usa, Hospira, Luitpold, Mylan Labs Ltd, Sagent Pharms, Teva Parenteral, and West-ward Pharms Int, and is included in twelve NDAs. It is available from four suppliers. Additional details are available on the LEUCOVORIN CALCIUM PRESERVATIVE FREE profile page.

The generic ingredient in LEUCOVORIN CALCIUM PRESERVATIVE FREE is leucovorin calcium. There are nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for 200753

Tradename:	LEUCOVORIN CALCIUM PRESERVATIVE FREE
Applicant:	Sagent Pharms
Ingredient:	leucovorin calcium
Patents:	0
Formulation / Manufacturing:	see details

Pharmacology for NDA: 200753

Ingredient-type	Folic Acid Analogs/Derivatives

Medical Subject Heading (MeSH) Categories for 200753

Antidotes
Vitamin B Complex

Suppliers and Packaging for NDA: 200753

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
LEUCOVORIN CALCIUM PRESERVATIVE FREE	leucovorin calcium	INJECTABLE;INJECTION	200753	ANDA	Sagent Pharmaceuticals	25021-813	N	25021-813-66
LEUCOVORIN CALCIUM PRESERVATIVE FREE	leucovorin calcium	INJECTABLE;INJECTION	200753	ANDA	Sagent Pharmaceuticals	25021-813	N	25021-813-10

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/VIAL
Approval Date:	Sep 6, 2012	TE:	AP	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 100MG BASE/VIAL
Approval Date:	Sep 6, 2012	TE:	AP	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 200MG BASE/VIAL
Approval Date:	Sep 6, 2012	TE:	AP	RLD:	No

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