NDA 22545, held by Novartis. Aliskiren Hemifumarate; Amlodipine Besylate.
As of Nov 14, 2026, NDA 22545 (Tekamlo), held by Novartis, was first approved by FDA on Aug 26, 2010, with 13 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 26, 2010 | Original applicationNew combination · Standard review | Approved |
| TekamloEQ 150MG BASE;EQ 5MG BASE · tablet;oral | Aliskiren Hemifumarate; Amlodipine Besylate | Discontinued |
| TekamloEQ 150MG BASE;EQ 10MG BASE · tablet;oral | Aliskiren Hemifumarate; Amlodipine Besylate | Discontinued |
| TekamloEQ 300MG BASE;EQ 5MG BASE · tablet;oral | Aliskiren Hemifumarate; Amlodipine Besylate | Discontinued |
| TekamloEQ 300MG BASE;EQ 10MG BASE · tablet;oral | Aliskiren Hemifumarate; Amlodipine Besylate | Discontinued |
| Nov 4, 2016 | Supplement 20Labeling · Standard review | Approved | |
| Dec 22, 2015 | Supplement 17Labeling · Standard review | Approved | |
| Mar 27, 2015 | Supplement 16Labeling · Standard review | Approved | |
| Mar 18, 2014 | Supplement 15Labeling · Standard review | Approved | |
| Nov 4, 2013 | Supplement 14Labeling · Standard review | Approved | |
| Sep 28, 2012 | Supplement 11Labeling | Approved | |
| Sep 28, 2012 | Supplement 13Labeling | Approved | |
| Apr 16, 2012 | Supplement 12Labeling | Approved | |
| Feb 2, 2012 | Supplement 10Labeling | Approved | |
| Jan 26, 2012 | Supplement 7Labeling | Approved | |
| Nov 14, 2011 | Supplement 8Labeling | Approved | |
| Oct 12, 2011 | Supplement 5Labeling | Approved | |
| Mar 30, 2011 | Supplement 1Labeling · Standard review | Approved | |
| Aug 26, 2010 | Original applicationNew combination · 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
