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Generated: December 12, 2018

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Details for New Drug Application (NDA): 203800

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NDA 203800 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. Ten suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 203800
Tradename:LEUCOVORIN CALCIUM PRESERVATIVE FREE
Applicant:Mylan Labs Ltd
Ingredient:leucovorin calcium
Patents:0
Formulation / Manufacturing:see details
Medical Subject Heading (MeSH) Categories for 203800

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:May 19, 2017TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:May 19, 2017TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 350MG BASE/VIAL
Approval Date:May 19, 2017TE:APRLD:No

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