Proferdex

NDA 17807, held by New River. Iron Dextran.

As of Nov 13, 2026, NDA 17807 (Proferdex), held by New River, was first approved by FDA on Mar 26, 1981, with 7 approved supplements and 0 published complete response letters.

First approved: Mar 26, 1981
Review: Standard
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Mar 26, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
ProferdexEQ 50MG IRON/ML · injectable;injection	Iron Dextran	Discontinued

All 8 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Mar 6, 1989	Supplement 7Manufacturing · Standard review	Approved	None posted
Oct 31, 1986	Supplement 6Manufacturing · Standard review	Approved	None posted
Apr 17, 1986	Supplement 3Labeling	Approved	None posted
Nov 19, 1984	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 3, 1984	Supplement 5Manufacturing · Standard review	Approved	None posted
Jan 4, 1984	Supplement 2Manufacturing · Standard review	Approved	None posted
Nov 5, 1982	Supplement 1Labeling	Approved	None posted
Mar 26, 1981	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 17807
Drugs@FDA: Overview at FDA
Company: New River Pharmaceuticals

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