Amlodipine Besylate

ANDA 78231, held by Sun Pharm Inds Inc. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 78231 (Amlodipine Besylate), held by Sun Pharm Inds Inc, was first approved by FDA on Nov 30, 2007, with 1 approved supplement and 0 published complete response letters.

First approved: Nov 30, 2007
Supplements approved: 1
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 2 submissions below

Date	Submission	Status	Documents
Nov 30, 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 2 submissions, including labeling and manufacturing supplements


Jan 15, 2009	Supplement 2Labeling	Approved	None posted
Nov 30, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 78231
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