Amlodipine Besylate

Treats hypertension. ANDA 76846, held by Teva. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 76846 (Amlodipine Besylate), held by Teva, was first approved by FDA on Jun 28, 2007, with 10 approved supplements and 0 published complete response letters.

First approved: Jun 28, 2007
Supplements approved: 10
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 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 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 11 submissions below

Date	Submission	Status	Documents
Jun 28, 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 11 submissions, including labeling and manufacturing supplements


Mar 14, 2018	Supplement 16Labeling · Standard review	Approved	None posted
Oct 1, 2015	Supplement 14Labeling · Standard review	Approved	None posted
Aug 30, 2013	Supplement 12Labeling · Standard review	Approved	None posted
May 2, 2013	Supplement 13Manufacturing	Approved	None posted
Dec 31, 2011	Supplement 10Labeling	Approved	None posted
Jul 27, 2011	Supplement 8Labeling	Approved	None posted
Apr 9, 2010	Supplement 7Labeling	Approved	None posted
Mar 12, 2009	Supplement 6Labeling	Approved	None posted
Apr 14, 2008	Supplement 4Labeling	Approved	None posted
Aug 30, 2007	Supplement 1Labeling	Approved	None posted
Jun 28, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 76846
Drugs@FDA: Overview at FDA
Company: Teva Pharmaceutical Industries

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