Amlodipine Besylate

ANDA 77262, held by Hikma. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 77262 (Amlodipine Besylate), held by Hikma, was first approved by FDA on Jul 9, 2007, with 5 approved supplements and 0 published complete response letters.

First approved: Jul 9, 2007
Supplements approved: 5
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Jul 9, 2007	Original application	Approved	None posted

Products

3 strengths and forms


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

All 6 submissions, including labeling and manufacturing supplements


Apr 2, 2018	Supplement 6Labeling · Standard review	Approved	None posted
Sep 18, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Sep 25, 2014	Supplement 4Labeling · Standard review	Approved	None posted
Jan 20, 2012	Supplement 2Labeling	Approved	None posted
Apr 13, 2010	Supplement 1Labeling	Approved	None posted
Jul 9, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77262
Drugs@FDA: Overview at FDA
Company: Hikma

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