Iron sucrose
Iron sucrose: 1 brand, 3 generics; first approved Nov 06, 2000; generic available.
Generic available: 3 ANDA applications approved.
Brand (NDA) products
- VENOFERRLDAM REGENTNDA 02113520055 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB EQ 75MG IRON/3.75ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Discontinued — EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Discontinued —
Generic (ANDA) products (3)
- IRON SUCROSEINTL MEDICATION SYSANDA 20897720253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB - IRON SUCROSEMYLAN LABS LTDANDA 21255920253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB - IRON SUCROSESANDOZANDA 21234020253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE INTRAVENOUS Rx AB
Patent & exclusivity timeline
Marketing exclusivity
- CGTFDA marketing exclusivity
8 mo ago
- CGTFDA marketing exclusivity
8 mo ago
- CGTFDA marketing exclusivity
8 mo ago
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Approval history
Approvals span 2000–2025 across 4 FDA applications.
Iron sucrose: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
