NDA 21179, held by Genzyme. Sevelamer Hydrochloride.
As of Nov 14, 2026, NDA 21179 (Renagel), held by Genzyme, was first approved by FDA on Jul 12, 2000, with 13 approved supplements and 0 published complete response letters.
| Oct 19, 2007 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Feb 6, 2004 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jul 12, 2000 | Original applicationNew dosage form · Standard review | Approved |
| Renagel400MG · tablet;oral | Sevelamer Hydrochloride | RxReference drug |
| Renagel800MG · tablet;oral | Sevelamer Hydrochloride | RxReference drug |
| Dec 22, 2023 | Supplement 39Manufacturing · Standard review | Approved | |
| Apr 30, 2020 | Supplement 38Labeling · Standard review | Approved | |
| Feb 21, 2019 | Supplement 37Labeling · Standard review | Approved | |
| Mar 9, 2016 | Supplement 32Labeling · Standard review | Approved | |
| Jun 9, 2015 | Supplement 31Manufacturing · Standard review | Approved | None posted |
| Nov 26, 2014 | Supplement 30Labeling · Standard review | Approved | |
| Jun 16, 2011 | Supplement 29Labeling | Approved | |
| Oct 19, 2007 | Supplement 20Efficacy (new indication or use) · Standard review | Approved | |
| Aug 14, 2007 | Supplement 21Labeling · Standard review | Approved | |
| Jul 25, 2005 | Supplement 15Labeling · Standard review | Approved | |
| Feb 6, 2004 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Jan 7, 2003 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Mar 15, 2002 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Jul 12, 2000 | Original applicationNew dosage form · Standard review | Approved |
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
