Feridex I.V.

NDA 20416, held by Amag Pharms Inc. Ferumoxides.

As of Nov 14, 2026, NDA 20416 (Feridex I.V.), held by Amag Pharms Inc, was first approved by FDA on Aug 30, 1996, with 1 approved supplement and 0 published complete response letters.

First approved: Aug 30, 1996
Review: Standard
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Aug 30, 1996	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Feridex I.V.EQ 11.2MG IRON/ML · injectable;injection	Ferumoxides	Discontinued

All 2 submissions, including labeling and manufacturing supplements


Oct 11, 1996	Supplement 1Labeling · Standard review	Approved	None posted
Aug 30, 1996	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20416
Drugs@FDA: Overview at FDA
Company: AMAG Pharmaceuticals, Inc.

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters