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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 218200


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NDA 218200 describes LEUCOVORIN CALCIUM, which is a drug marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, Gland, Hainan Poly, Hikma, Meitheal, Pharmachemie, Pharmachemie Usa, Teva Parenteral, Teva Pharms Usa, Fresenius Kabi Usa, Novast Labs, Ani Pharms, Barr, Epic Pharma Llc, Leading, Par Pharm, Xanodyne Pharm, Am Regent, Mylan Labs Ltd, Sagent Pharms, and Sagent Pharms Inc, and is included in forty-nine NDAs. It is available from fourteen 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. Sixteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 218200
Tradename:LEUCOVORIN CALCIUM
Applicant:Gland
Ingredient:leucovorin calcium
Patents:0
Pharmacology for NDA: 218200
Medical Subject Heading (MeSH) Categories for 218200
Antidotes
Vitamin B Complex
Suppliers and Packaging for NDA: 218200
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUCOVORIN CALCIUM leucovorin calcium INJECTABLE;INJECTION 218200 ANDA Gland Pharma Limited 68083-587 68083-587-01 1 VIAL in 1 CARTON (68083-587-01) / 17.5 mL in 1 VIAL
LEUCOVORIN CALCIUM leucovorin calcium INJECTABLE;INJECTION 218200 ANDA GLENMARK PHARMACEUTICALS INC., USA 68462-767 68462-767-35 1 VIAL in 1 CARTON (68462-767-35) / 17.5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 350MG BASE/VIAL
Approval Date:Nov 12, 2025TE:APRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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