Amlodipine Besylate

Treats hypertension. ANDA 78552, held by Epic Pharma LLC. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 78552 (Amlodipine Besylate), held by Epic Pharma LLC, was first approved by FDA on Apr 8, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 8, 2009
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Amlodipine besylate tablets are a calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of:

Hypertension o 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.
Coronary Artery Disease o Chronic Stable Angina o Vasospastic Angina (Prinzmetal’s or Variant Angina) o Angiographically Documented Coronary Artery Disease in patients without heart failure or an ejection fraction < 40%. 1.1 Hypertension

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 7 submissions below

Date	Submission	Status	Documents
Apr 8, 2009	Original application	Approved	None posted

Products

3 strengths and forms


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

All 7 submissions, including labeling and manufacturing supplements


Jun 17, 2025	Supplement 15Labeling · Standard review	Approved	None posted
Apr 26, 2018	Supplement 10Labeling · Standard review	Approved	None posted
Oct 19, 2015	Supplement 6Labeling · Standard review	Approved	None posted
Jan 27, 2015	Supplement 3Manufacturing	Approved	None posted
Aug 30, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Aug 30, 2013	Supplement 4Labeling · Standard review	Approved	None posted
Apr 8, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78552
Drugs@FDA: Overview at FDA
Company: Epic Pharma

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