Last Updated: May 3, 2026

Details for New Drug Application (NDA): 008107


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NDA 008107 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, Ingenus Pharms Llc, Ani Pharms, Barr, Epic Pharma Llc, Leading, Novast Labs, 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. Seventeen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 008107
Tradename:LEUCOVORIN CALCIUM
Applicant:Hospira
Ingredient:leucovorin calcium
Patents:0
Medical Subject Heading (MeSH) Categories for 008107
Antidotes
Vitamin B Complex

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SOLUTION;INTRAMUSCULAR, INTRAVENOUSStrengthEQ 3MG BASE/ML (EQ 3MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:FOR SOLUTION;ORALStrengthEQ 60MG BASE/VIAL
Approval Date:Jan 30, 1987TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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