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Serving 500+ biopharmaceutical companies globally:

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Generated: June 26, 2017

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 Mylan Labs Ltd, Teva Parenteral, West-ward Pharms Int, Luitpold, Hospira, Sagent Pharms, and Fresenius Kabi Usa, and is included in eleven 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 NDA: 200753

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 200753

Ingredient-typeFolic Acid
Analogs/Derivatives

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 25021-813-66 10 VIAL in 1 CARTON (25021-813-66) > 5 mL in 1 VIAL
LEUCOVORIN CALCIUM PRESERVATIVE FREE
leucovorin calcium
 INJECTABLE;INJECTION 200753 ANDA Sagent Pharmaceuticals 25021-813 25021-813-10 10 VIAL in 1 CARTON (25021-813-10) > 5 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Sep 6, 2012TE:APRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:Sep 6, 2012TE:APRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Sep 6, 2012TE:APRLD:No


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Serving 500+ biopharmaceutical companies globally:

Medtronic
Cipla
Farmers Insurance
Express Scripts
AstraZeneca
Harvard Business School
Daiichi Sankyo
Chinese Patent Office
Fish and Richardson
Deloitte

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