Iron Sucrose
ANDA 212559, held by Mylan Labs Ltd. Iron Sucrose.
- First approved: Aug 8, 2025
- Review: Standard
- Supplements approved: 0
- Complete response letters: 0
Approvals and New Uses
The original application and every efficacy supplement, newest first| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 8, 2025 | Original application | Approved | None posted |
Products
3 strengths and forms| Product | Active ingredient | Marketing |
|---|---|---|
| Iron SucroseEQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) · injectable;intravenous | Iron Sucrose | Discontinued |
| Iron SucroseEQ 100MG IRON/5ML (EQ 20MG IRON/ML) · injectable;intravenous | Iron Sucrose | Rx |
| Iron SucroseEQ 200MG IRON/10ML (EQ 20MG IRON/ML) · injectable;intravenous | Iron Sucrose | Rx |
Identifiers
- Application
- ANDA 212559
- Drugs@FDA
- Overview at FDA
- Company
- Mylan Laboratories
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters