Renagel

NDA 20926, held by Genzyme. Sevelamer Hydrochloride.

As of Nov 13, 2026, NDA 20926 (Renagel), held by Genzyme, was first approved by FDA on Oct 30, 1998, with 6 approved supplements and 0 published complete response letters.

First approved: Oct 30, 1998
Review: Standard
Supplements approved: 6
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below


Feb 6, 2004	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
May 5, 2000	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 30, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Renagel403MG · capsule;oral	Sevelamer Hydrochloride	Discontinued

All 7 submissions, including labeling and manufacturing supplements


Feb 6, 2004	Supplement 6Efficacy (new indication or use) · Standard review	Approved	Letter
Aug 8, 2002	Supplement 5Manufacturing · Standard review	Approved	None posted
Mar 15, 2002	Supplement 4Manufacturing · Standard review	Approved	None posted
Oct 13, 2000	Supplement 3Manufacturing · Standard review	Approved	None posted
May 5, 2000	Supplement 2Efficacy (new indication or use) · Standard review	Approved	Letter
Oct 1, 1999	Supplement 1Manufacturing · Standard review	Approved	None posted
Oct 30, 1998	Original applicationNew molecular entity · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 20926
Drugs@FDA: Overview at FDA
Company: Genzyme

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