Amlodipine Besylate

Treats hypertension. ANDA 78925, held by Alkem. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 78925 (Amlodipine Besylate), held by Alkem, was first approved by FDA on May 4, 2009, with 6 approved supplements and 0 published complete response letters.

First approved: May 4, 2009
Supplements approved: 6
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Amlodipine besylate tablets 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 besylate tablets 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

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
May 4, 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


Jan 3, 2025	Supplement 25Manufacturing	Approved	None posted
Oct 2, 2017	Supplement 10Labeling · Standard review	Approved	None posted
Nov 24, 2015	Supplement 7Labeling · Standard review	Approved	None posted
Sep 21, 2014	Supplement 5Labeling · Standard review	Approved	None posted
Jul 9, 2013	Supplement 2Manufacturing	Approved	None posted
Apr 20, 2010	Supplement 1Labeling	Approved	None posted
May 4, 2009	Original application	Approved	None posted

Identifiers

Application: ANDA 78925
Drugs@FDA: Overview at FDA
Company: Alkem Laboratories

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