Treats hypertension. ANDA 203245, held by Unichem. Amlodipine Besylate.
As of Nov 15, 2026, ANDA 203245 (Amlodipine Besylate), held by Unichem, was first approved by FDA on Oct 21, 2013, with 3 approved supplements and 0 published complete response letters.
1.1 Hypertension Amlodipine besylate tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal 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 besylate tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 21, 2013 | Original application | Approved | None posted |
| Amlodipine BesylateEQ 2.5MG BASE · tablet;oral | Amlodipine Besylate | Rx |
| Amlodipine BesylateEQ 5MG BASE · tablet;oral | Amlodipine Besylate | Rx |
| Amlodipine BesylateEQ 10MG BASE · tablet;oral | Amlodipine Besylate | Rx |
| Apr 26, 2018 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jan 4, 2017 | Supplement 4Manufacturing | Approved | None posted |
| Jan 19, 2016 | Supplement 3Labeling · Standard review | Approved | None posted |
| Oct 21, 2013 | Original application | Approved | None posted |
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
