Amlodipine Besylate

ANDA 77974, held by Sun Pharm Inds Ltd. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 77974 (Amlodipine Besylate), held by Sun Pharm Inds Ltd, was first approved by FDA on Jul 9, 2007, with 4 approved supplements and 0 published complete response letters.

First approved: Jul 9, 2007
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
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 5 submissions, including labeling and manufacturing supplements


Apr 3, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Apr 3, 2018	Supplement 5Labeling · Standard review	Approved	None posted
Oct 6, 2015	Supplement 3Labeling · Standard review	Approved	None posted
Sep 21, 2014	Supplement 2Labeling · Standard review	Approved	None posted
Jul 9, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77974
Drugs@FDA: Overview at FDA
Company: Sun Pharmaceutical Industries

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