Amlodipine Besylate

Treats hypertension. ANDA 201380, held by Graviti Pharms. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 201380 (Amlodipine Besylate), held by Graviti Pharms, was first approved by FDA on Apr 13, 2012, with 6 approved supplements and 0 published complete response letters.

First approved: Apr 13, 2012
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 ○ 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 7 submissions below

Date	Submission	Status	Documents
Apr 13, 2012	Original application	Approved	None posted

Products

3 strengths and forms


Amlodipine BesylateEQ 5MG BASE · tablet;oral	Amlodipine Besylate	Rx
Amlodipine BesylateEQ 10MG BASE · tablet;oral	Amlodipine Besylate	Rx
Amlodipine BesylateEQ 2.5MG BASE · tablet;oral	Amlodipine Besylate	Rx

All 7 submissions, including labeling and manufacturing supplements


Feb 17, 2026	Supplement 23Manufacturing	Approved	None posted
Jan 26, 2026	Supplement 22Manufacturing	Approved	None posted
Jun 7, 2023	Supplement 17Labeling · Standard review	Approved	None posted
Apr 3, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Dec 3, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Sep 19, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Apr 13, 2012	Original application	Approved	None posted

Identifiers

Application: ANDA 201380
Drugs@FDA: Overview at FDA
Company: Graviti Pharmaceuticals

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