Assyro AI

Orange Book product · Brand (NDA)

VENOFER

IRON SUCROSE

Brand (NDA)NDA 021135DISCN AM REGENT

At a glance

Mar 29, 2013

Approved

Brand (NDA)

Application

Not listed

TE code

None

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Mar 29, 2013

    13 yr 5 mo ago

  2. Today

Pharmaceutical detail

Active ingredient

IRON SUCROSE

Strength

EQ 65MG IRON/3.25ML (EQ 20MG IRON/ML)

Dosage form

INJECTABLE

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 021135

Product number

005

Marketing status

DISCN

Reference listed drug (RLD)

No

Reference standard (RS)

No

Active-ingredient family

View full family

This is a brand (NDA) product. Other products sharing this active 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

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.