Amlodipine Besylate

ANDA 78477, held by Amneal Pharms Ny. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 78477 (Amlodipine Besylate), held by Amneal Pharms Ny, was first approved by FDA on Jan 16, 2008, with 8 approved supplements and 0 published complete response letters.

First approved: Jan 16, 2008
Supplements approved: 8
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 9 submissions below

Date	Submission	Status	Documents
Jan 16, 2008	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 9 submissions, including labeling and manufacturing supplements


Apr 5, 2018	Supplement 19Labeling · Standard review	Approved	None posted
Nov 24, 2015	Supplement 18Labeling · Standard review	Approved	None posted
Sep 26, 2014	Supplement 16Labeling · Standard review	Approved	None posted
Nov 1, 2011	Supplement 12Manufacturing	Approved	None posted
Nov 1, 2011	Supplement 6Manufacturing	Approved	None posted
Nov 1, 2011	Supplement 5Labeling	Approved	None posted
Jul 26, 2011	Supplement 13Labeling	Approved	None posted
May 27, 2010	Supplement 9Labeling	Approved	None posted
Jan 16, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78477
Drugs@FDA: Overview at FDA
Company: Amneal Pharmaceuticals of New York

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