Last Updated: September 24, 2026

Details for New Drug Application (NDA): 208977


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NDA 208977 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 is one drug master file entry for this compound. Six suppliers are listed for this compound. Additional details are available on the iron sucrose profile page.
Summary for 208977
Tradename:IRON SUCROSE
Applicant:Intl Medication Sys
Ingredient:iron sucrose
Patents:0
Pharmacology for NDA: 208977
Mechanism of ActionPhosphate Chelating Activity
Suppliers and Packaging for NDA: 208977
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 208977 ANDA International Medication Systems, Limited 76329-9200 76329-9200-1 10 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9200-1) / 2.5 mL in 1 VIAL, SINGLE-DOSE
IRON SUCROSE iron sucrose INJECTABLE;INTRAVENOUS 208977 ANDA International Medication Systems, Limited 76329-9201 76329-9201-1 10 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9201-1) / 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
Regulatory Exclusivity Expiration:Feb 8, 2026
Regulatory Exclusivity Use:COMPETITIVE GENERIC THERAPY

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