Amlodipine Besylate

Treats hypertension. ANDA 78043, held by Lupin. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 78043 (Amlodipine Besylate), held by Lupin, was first approved by FDA on Jul 12, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 12, 2007
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

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

Hypertension о 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 о Chronic Stable Angina о Vasospastic Angina (Prinzmetal's or Variant Angina) о 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 6 submissions below

Date	Submission	Status	Documents
Jul 12, 2007	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 6 submissions, including labeling and manufacturing supplements


May 21, 2018	Supplement 19Labeling · Standard review	Approved	None posted
Sep 18, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 15Labeling · Standard review	Approved	None posted
Aug 26, 2013	Supplement 13Labeling · Standard review	Approved	None posted
Oct 22, 2010	Supplement 8Labeling	Approved	None posted
Jul 12, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78043
Drugs@FDA: Overview at FDA
Company: Lupin

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