Venlafaxine Besylate

NDA 215429, held by Almatica. Venlafaxine Besylate.

As of Nov 13, 2026, NDA 215429 (Venlafaxine Besylate), held by Almatica, was first approved by FDA on Jun 29, 2022, with 1 approved supplement and 0 published complete response letters.

First approved: Jun 29, 2022
Review: Standard
Supplements approved: 1
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Venlafaxine Extended-Release Tablets are indicated in adults for the treatment of: Major depressive disorder (MDD) Generalized Anxiety Disorder (GAD) Venlafaxine Extended-Release Tablets are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated in adults for the treatment of: Major Depressive Disorder (MDD) Generalized Anxiety Disorder (GAD)

Full prescribing information on DailyMed ↗

Approvals and New Uses

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


Jun 29, 2022	Original applicationTYPE 2/3 · Standard review	Approved	Review Letter Label Medication Guide
Jun 29, 2022	Original applicationTYPE 2/3 · Standard review	Approved	Review Letter Label Medication Guide

Products

1 strengths and forms

Product	Active ingredient	Marketing
Venlafaxine BesylateEQ 112.5MG BASE · tablet, extended release;oral	Venlafaxine Besylate	RxReference drug

All 3 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 1Labeling · Standard review	Approved	Label Medication Guide Letter
Jun 29, 2022	Original applicationTYPE 2/3 · Standard review	Approved	Review Letter Label Medication Guide
Jun 29, 2022	Original applicationTYPE 2/3 · Standard review	Approved	Review Letter Label Medication Guide

Identifiers

Application: NDA 215429
Drugs@FDA: Overview at FDA
Company: Almatica Pharma

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