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Generated: November 17, 2018

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Details for New Drug Application (NDA): 200753

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NDA 200753 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. Nine suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 200753
Tradename:LEUCOVORIN CALCIUM PRESERVATIVE FREE
Applicant:Sagent Pharms
Ingredient:leucovorin calcium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 200753
Medical Subject Heading (MeSH) Categories for 200753
Suppliers and Packaging for NDA: 200753
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUCOVORIN CALCIUM PRESERVATIVE FREE leucovorin calcium INJECTABLE;INJECTION 200753 ANDA Sagent Pharmaceuticals 25021-813 25021-813-66 10 VIAL in 1 CARTON (25021-813-66) > 5 mL in 1 VIAL
LEUCOVORIN CALCIUM PRESERVATIVE FREE leucovorin calcium INJECTABLE;INJECTION 200753 ANDA Sagent Pharmaceuticals 25021-813 25021-813-10 10 VIAL in 1 CARTON (25021-813-10) > 5 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Sep 6, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:Sep 6, 2012TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Sep 6, 2012TE:APRLD:No

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