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Generated: April 29, 2017

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Details for New Drug Application (NDA): 040056

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NDA 040056 describes LEUCOVORIN CALCIUM PRESERVATIVE FREE, which is a drug marketed by Teva Parenteral, West-ward Pharms Int, Luitpold, Hospira, Sagent Pharms, and Fresenius Kabi Usa, and is included in ten 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: 040056

Formulation / Manufacturing:see details

Pharmacology for NDA: 040056

Suppliers and Packaging for NDA: 040056

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
leucovorin calcium
INJECTABLE;INJECTION 040056 ANDA West-Ward Pharmaceuticals Corp 0143-9553 0143-9553-01 1 VIAL in 1 BOX, UNIT-DOSE (0143-9553-01) > 20 mL in 1 VIAL

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:May 23, 1995TE:APRLD:No

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