Treats hypertension. NDA 21540, held by Pharmacia. Amlodipine Besylate; Atorvastatin Calcium.
As of Nov 14, 2026, NDA 21540 (Caduet), held by Pharmacia, was first approved by FDA on Jan 30, 2004, with 31 approved supplements and 0 published complete response letters.
Amlodipine and atorvastatin tablets are indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate. Amlodipine Hypertension Amlodipine is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including amlodipine.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 30, 2004 | Original applicationNew combination · Standard review | Approved |
| CaduetEQ 5MG BASE;EQ 10MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 5MG BASE;EQ 20MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 5MG BASE;EQ 40MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 5MG BASE;EQ 80MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 10MG BASE;EQ 10MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 10MG BASE;EQ 20MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 10MG BASE;EQ 40MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 10MG BASE;EQ 80MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 2.5MG BASE;EQ 10MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 2.5MG BASE;EQ 20MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| CaduetEQ 2.5MG BASE;EQ 40MG BASE · tablet;oral | Amlodipine Besylate; Atorvastatin Calcium | RxReference drug |
| Nov 4, 2024 | Supplement 50Labeling · Standard review | Approved | |
| May 17, 2024 | Supplement 49Labeling · Standard review | Approved | |
| Jan 7, 2021 | Supplement 46Labeling · Standard review | Approved | |
| Dec 15, 2020 | Supplement 47Labeling · Standard review | Approved | |
| Sep 25, 2020 | Supplement 48Labeling · Standard review | Approved | |
| Dec 18, 2019 | Supplement 45Labeling · Standard review | Approved | |
| May 10, 2019 | Supplement 44Labeling · Standard review | Approved | |
| Sep 12, 2018 | Supplement 43Labeling · Standard review | Approved | |
| Sep 12, 2018 | Supplement 42Labeling · Standard review | Approved | |
| May 25, 2018 | Supplement 41Labeling · Standard review | Approved | |
| Oct 30, 2017 | Supplement 38Labeling · Standard review | Approved | |
| Jun 23, 2017 | Supplement 39Labeling · Standard review | Approved | |
| Mar 23, 2015 | Supplement 36Labeling · Standard review | Approved | |
| Feb 17, 2015 | Supplement 37Labeling · Standard review | Approved | |
| Jul 28, 2014 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| May 22, 2014 | Supplement 34Labeling · Standard review | Approved | |
| Apr 21, 2014 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Nov 7, 2013 | Supplement 31Labeling · Standard review | Approved | |
| Nov 7, 2013 | Supplement 30Labeling · Standard review | Approved | |
| Jul 31, 2013 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Oct 31, 2012 | Supplement 28Labeling | Approved | |
| Jul 26, 2012 | Supplement 26Labeling | Approved | |
| Jul 26, 2012 | Supplement 23Labeling | Approved | |
| Feb 17, 2010 | Supplement 19Labeling | Approved | |
| Jul 20, 2009 | Supplement 18Labeling · Standard review | Approved | |
| May 29, 2008 | Supplement 14Labeling · Standard review | Approved | |
| Sep 20, 2007 | Supplement 11Labeling · Standard review | Approved | |
| Sep 20, 2007 | Supplement 9Labeling · Standard review | Approved | |
| Aug 28, 2006 | Supplement 6Labeling · Standard review | Approved | |
| Apr 13, 2006 | Supplement 8Labeling · Standard review | Approved | |
| Sep 27, 2004 | Supplement 3Labeling · Standard review | Approved | |
| Jan 30, 2004 | 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
