Amlodipine Besylate

ANDA 77516, held by Strides Pharma. Amlodipine Besylate.

As of Nov 15, 2026, ANDA 77516 (Amlodipine Besylate), held by Strides Pharma, was first approved by FDA on Jul 11, 2007, with 2 approved supplements and 0 published complete response letters.

First approved: Jul 11, 2007
Supplements approved: 2
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
Jul 11, 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 3 submissions, including labeling and manufacturing supplements


Apr 23, 2018	Supplement 4Labeling · Standard review	Approved	None posted
Oct 28, 2015	Supplement 1Manufacturing	Approved	None posted
Jul 11, 2007	Original application	Approved	None posted

Identifiers

Application: ANDA 77516
Drugs@FDA: Overview at FDA
Company: Strides Pharma Inc

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