Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200753

« Back to Dashboard

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. Nine 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

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Julphar

Boehringer Ingelheim

Merck

Medtronic

Express Scripts

Moodys

Cantor Fitzgerald

Daiichi Sankyo

Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.