Amlodipine Besylate

ANDA 78573, held by Torrent Pharms. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 78573 (Amlodipine Besylate), held by Torrent Pharms, was first approved by FDA on Sep 22, 2008, with 7 approved supplements and 0 published complete response letters.

First approved: Sep 22, 2008
Supplements approved: 7
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 8 submissions below

Date	Submission	Status	Documents
Sep 22, 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 8 submissions, including labeling and manufacturing supplements


Mar 22, 2019	Supplement 17Labeling · Standard review	Approved	None posted
Jan 21, 2015	Supplement 5Labeling	Approved	None posted
Sep 24, 2014	Supplement 13Labeling · Standard review	Approved	None posted
Feb 27, 2012	Supplement 12Labeling	Approved	None posted
Jul 21, 2011	Supplement 11Labeling	Approved	None posted
May 14, 2010	Supplement 4Labeling	Approved	None posted
Apr 9, 2010	Supplement 9Labeling	Approved	None posted
Sep 22, 2008	Original application	Approved	None posted

Identifiers

Application: ANDA 78573
Drugs@FDA: Overview at FDA
Company: Torrent 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