Home Applications 212340 Application 212340
Type ANDA
Sponsor SANDOZ Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 IRON SUCROSE IRON SUCROSE INJECTABLE;INTRAVENOUS EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) No No 002 IRON SUCROSE IRON SUCROSE INJECTABLE;INTRAVENOUS EQ 100MG IRON/5ML (EQ 20MG IRON/ML) No No 003 IRON SUCROSE IRON SUCROSE INJECTABLE;INTRAVENOUS EQ 200MG IRON/10ML (EQ 20MG IRON/ML) No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A212340-001 IRON SUCROSE IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 A212340-002 IRON SUCROSE IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 A212340-003 IRON SUCROSE IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A212340-001 IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212340-002 IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A212340-003 IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212340-001 IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212340-002 IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212340-003 IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 31067a03dcf5…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212340-001 IRON SUCROSE EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212340-002 IRON SUCROSE EQ 100MG IRON/5ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212340-003 IRON SUCROSE EQ 200MG IRON/10ML (EQ 20MG IRON/ML) INJECTABLE / INTRAVENOUS AB 2025-08-08 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Documents# Document, Submission type, Date table Document Submission type Date 85120 ORIG 2026-02-24