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Generated: August 20, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040286

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NDA 040286 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: 040286

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040286

Suppliers and Packaging for NDA: 040286

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUCOVORIN CALCIUM PRESERVATIVE FREE
leucovorin calcium
INJECTABLE;INJECTION 040286 ANDA Fresenius Kabi USA, LLC 63323-711 63323-711-00 1 VIAL in 1 BOX (63323-711-00) > 50 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Feb 26, 1999TE:RLD:No


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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
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Argus Health
Dow
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