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Generated: November 20, 2018

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Details for New Drug Application (NDA): 040286

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NDA 040286 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 040286
Tradename:LEUCOVORIN CALCIUM PRESERVATIVE FREE
Applicant:Fresenius Kabi Usa
Ingredient:leucovorin calcium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 040286
Medical Subject Heading (MeSH) Categories for 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

Profile for product number 001

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

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