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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 217021


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NDA 217021 describes LEUCOVORIN CALCIUM, which is a drug marketed by Hospira, Abic, Abraxis Pharm, Elkins Sinn, 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-eight NDAs. It is available from twelve 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. Fourteen suppliers are listed for this compound. Additional details are available on the leucovorin calcium profile page.
Summary for 217021
Tradename:LEUCOVORIN CALCIUM
Applicant:Hainan Poly
Ingredient:leucovorin calcium
Patents:0
Pharmacology for NDA: 217021
Medical Subject Heading (MeSH) Categories for 217021
Suppliers and Packaging for NDA: 217021
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
LEUCOVORIN CALCIUM leucovorin calcium INJECTABLE;INJECTION 217021 ANDA Slate Run Pharmaceuticals, LLC 70436-116 70436-116-82 10 VIAL in 1 BOX (70436-116-82) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70436-116-80)
LEUCOVORIN CALCIUM leucovorin calcium INJECTABLE;INJECTION 217021 ANDA Slate Run Pharmaceuticals, LLC 70436-117 70436-117-80 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (70436-117-80)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Jul 10, 2023TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 100MG BASE/VIAL
Approval Date:Jul 10, 2023TE:APRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 200MG BASE/VIAL
Approval Date:Jul 10, 2023TE:APRLD:No

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