Amlodipine Besylate

ANDA 77771, held by Hikma Pharms. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 77771 (Amlodipine Besylate), held by Hikma Pharms, was first approved by FDA on Apr 12, 2011, with 4 approved supplements and 0 published complete response letters.

First approved: Apr 12, 2011
Supplements approved: 4
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 5 submissions below

Date	Submission	Status	Documents
Apr 12, 2011	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 5 submissions, including labeling and manufacturing supplements


Feb 27, 2023	Supplement 7Labeling · Standard review	Approved	None posted
Sep 25, 2015	Supplement 4Labeling · Standard review	Approved	None posted
Sep 25, 2015	Supplement 5Labeling · Standard review	Approved	None posted
Nov 18, 2011	Supplement 3Labeling	Approved	None posted
Apr 12, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 77771
Drugs@FDA: Overview at FDA
Company: Hikma 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