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Details for New Drug Application (NDA): 040174

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NDA 040174 describes LEUCOVORIN CALCIUM, which is a drug marketed by Par Pharm, Pharmachemie, Xanodyne Pharm, Hospira, Pharmachemie Usa, West-ward Pharms Int, Elkins Sinn, Idt Australia Ltd, Roxane, Abraxis Pharm, Corepharma, Abic, Teva Pharms Usa, Teva Parenteral, Barr, Luitpold, Sagent Pharms, and Fresenius Kabi Usa, and is included in thirty-nine NDAs. It is available from eight suppliers. Additional details are available on the LEUCOVORIN CALCIUM profile page.

The generic ingredient in LEUCOVORIN CALCIUM is leucovorin calcium. There are nine drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.

Summary for NDA: 040174

Tradename:
LEUCOVORIN CALCIUM
Applicant:
Teva Pharms Usa
Ingredient:
leucovorin calcium
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 040174

Suppliers and Packaging for NDA: 040174

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUCOVORIN CALCIUM
leucovorin calcium
INJECTABLE;INJECTION 040174 ANDA Teva Parenteral Medicines, Inc. 0703-5145 0703-5145-91 1 VIAL, SINGLE-USE in 1 CARTON (0703-5145-91) > 17.5 mL in 1 VIAL, SINGLE-USE
LEUCOVORIN CALCIUM
leucovorin calcium
INJECTABLE;INJECTION 040174 ANDA Teva Parenteral Medicines, Inc. 0703-5145 0703-5145-01 1 VIAL, SINGLE-USE in 1 CARTON (0703-5145-01) > 17.5 mL in 1 VIAL, SINGLE-USE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 350MG BASE/VIAL
Approval Date:Jun 12, 1997TE:APRLD:No


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