Amlodipine Besylate

ANDA 76418, held by Mylan. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 76418 (Amlodipine Besylate), held by Mylan, was first approved by FDA on Oct 3, 2005, with 4 approved supplements and 0 published complete response letters.

First approved: Oct 3, 2005
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
Oct 3, 2005	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


Apr 3, 2018	Supplement 20Labeling · Standard review	Approved	None posted
Sep 25, 2015	Supplement 17Labeling · Standard review	Approved	None posted
Sep 21, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Mar 22, 2011	Supplement 12Labeling	Approved	None posted
Oct 3, 2005	Original application	Approved	None posted

Identifiers

Application: ANDA 76418
Drugs@FDA: Overview at FDA
Company: Mylan

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