Amlodipine Besylate

Treats hypertension. ANDA 77955, held by Invagen Pharms. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 77955 (Amlodipine Besylate), held by Invagen Pharms, was first approved by FDA on Aug 28, 2007, with 7 approved supplements and 0 published complete response letters.

First approved: Aug 28, 2007
Supplements approved: 7
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Amlodipine besylate, USP 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, USP 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 8 submissions below

Date	Submission	Status	Documents
Aug 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 8 submissions, including labeling and manufacturing supplements


Apr 20, 2018	Supplement 14Labeling · Standard review	Approved	None posted
Dec 21, 2015	Supplement 11Labeling · Standard review	Approved	None posted
Aug 26, 2013	Supplement 3Labeling	Approved	None posted
Aug 26, 2013	Supplement 5Labeling · Standard review	Approved	None posted
Aug 26, 2013	Supplement 8Labeling · Standard review	Approved	None posted
Feb 11, 2011	Supplement 2Labeling	Approved	None posted
Dec 4, 2009	Supplement 1Labeling	Approved	None posted
Aug 28, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77955
Drugs@FDA: Overview at FDA
Company: InvaGen Pharmaceuticals, Inc.

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