Assyro AI

Orange Book product · Brand (NDA)

VENOFER

IRON SUCROSE

Brand (NDA)NDA 021135TE ABRX AM REGENT
View IRON SUCROSE familyOpen on FDA Orange Book

At a glance

Mar 20, 2005

Approved

Brand (NDA)

Application

AB

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 20, 2005

    21 yr 7 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IRON SUCROSE

Strength

EQ 50MG IRON/2.5ML (EQ 20MG IRON/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

AB

Application

NDA 021135

Product number

002

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

No

Active-ingredient family

View full family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

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.

Agent CTA Background

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