Desvenlafaxine

NDA 205583, held by Sun Pharm. Desvenlafaxine Fumarate.

As of Nov 14, 2026, NDA 205583 (Desvenlafaxine), held by Sun Pharm, was first approved by FDA on Jan 28, 2014, with 7 approved supplements and 0 published complete response letters.

First approved: Jan 28, 2014
Review: Standard
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
Jan 28, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Products

2 strengths and forms


DesvenlafaxineEQ 50MG BASE · tablet, extended release;oral	Desvenlafaxine Fumarate	DiscontinuedReference drug
DesvenlafaxineEQ 100MG BASE · tablet, extended release;oral	Desvenlafaxine Fumarate	DiscontinuedReference drug

All 8 submissions, including labeling and manufacturing supplements


Aug 18, 2023	Supplement 14Labeling · Standard review	Approved	Letter Label Medication Guide
Dec 10, 2019	Supplement 10Labeling · Standard review	Approved	Letter Label
Dec 19, 2017	Supplement 6Labeling	Approved	Letter Label
Jan 4, 2017	Supplement 5Labeling	Approved	Letter Label
Feb 3, 2015	Supplement 4Manufacturing · Standard review	Approved	None posted
Jul 18, 2014	Supplement 1Labeling · Standard review	Approved	Letter Label
Jul 18, 2014	Supplement 3Labeling	Approved	Label Letter
Jan 28, 2014	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Label Letter

Identifiers

Application: NDA 205583
Drugs@FDA: Overview at FDA
Company: Sun 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