Gastromark

NDA 20410, held by Amag Pharms Inc. Ferumoxsil.

As of Nov 14, 2026, NDA 20410 (Gastromark), held by Amag Pharms Inc, was first approved by FDA on Dec 6, 1996, with 2 approved supplements and 0 published complete response letters.

First approved: Dec 6, 1996
Review: Standard
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Dec 6, 1996	Original applicationNew molecular entity · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
GastromarkEQ 0.175MG IRON/ML · suspension;oral	Ferumoxsil	Discontinued

All 3 submissions, including labeling and manufacturing supplements


Apr 5, 2013	Supplement 3Manufacturing · Standard review	Approved	None posted
Jul 30, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Dec 6, 1996	Original applicationNew molecular entity · Standard review	Approved	None posted

Identifiers

Application: NDA 20410
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