Treats hypertension. ANDA 90752, held by China Resources. Amlodipine Besylate.
As of Nov 15, 2026, ANDA 90752 (Amlodipine Besylate), held by China Resources, was first approved by FDA on Apr 15, 2011, with 4 approved supplements and 0 published complete response letters.
Amlodipine is a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of: Hypertension Amlodipine is 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 Coronary Artery Disease Chronic Stable Angina Vasospastic Angina (Prinzmetal's or Variant Angina) Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40% 1.1 Hypertension
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 15, 2011 | Original application | Approved | None posted |
| Amlodipine BesylateEQ 5MG BASE · tablet;oral | Amlodipine Besylate | Rx |
| Amlodipine BesylateEQ 10MG BASE · tablet;oral | Amlodipine Besylate | Rx |
| Amlodipine BesylateEQ 2.5MG BASE · tablet;oral | Amlodipine Besylate | Rx |
| Apr 23, 2018 | Supplement 3Labeling · Standard review | Approved | None posted |
| Apr 23, 2018 | Supplement 4Labeling · Standard review | Approved | None posted |
| May 16, 2016 | Supplement 1Manufacturing | Approved | None posted |
| Jan 14, 2016 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 15, 2011 | 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
