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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 212340


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NDA 212340 describes IRON SUCROSE, which is a drug marketed by Intl Medication Sys, Mylan Labs Ltd, and Sandoz, and is included in three NDAs. It is available from three suppliers. Additional details are available on the IRON SUCROSE profile page.

The generic ingredient in IRON SUCROSE is iron sucrose. There are eighty-two drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the iron sucrose profile page.
Summary for 212340
Tradename:IRON SUCROSE
Applicant:Sandoz
Ingredient:iron sucrose
Patents:0
Pharmacology for NDA: 212340
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 212340
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 212340 ANDA Sandoz Inc 0781-3485 0781-3485-95 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56)
IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 212340 ANDA Sandoz Inc 0781-3485 0781-3485-96 25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-96) / 2.5 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)
Approval Date:Aug 8, 2025TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 100MG IRON/5ML (EQ 20MG IRON/ML)
Approval Date:Aug 8, 2025TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrengthEQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Approval Date:Aug 8, 2025TE:ABRLD:No

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Preferred Citation:

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