Orange Book product · Generic (ANDA)
IRON SUCROSE
IRON SUCROSE
Generic (ANDA)ANDA 212559TE ABRX MYLAN LABS LTD
At a glance
Aug 08, 2025
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 08, 2025
11 mo ago
Exclusivity ends · CGT
FDA marketing exclusivity
Feb 07, 2026
4 mo ago
Today
Pharmaceutical detail
Active ingredient
IRON SUCROSE
Strength
EQ 200MG IRON/10ML (EQ 20MG IRON/ML)
Dosage form
INJECTABLE
Route
INTRAVENOUS
TE code
AB
Application
ANDA 212559
Product number
003
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of IRON SUCROSE
Marketing exclusivity (1)
- CGTFDA marketing exclusivity
Feb 07, 2026
4 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.
