Khedezla

NDA 204683, held by Osmotica Pharm Corp. Desvenlafaxine.

As of Nov 14, 2026, NDA 204683 (Khedezla), held by Osmotica Pharm Corp, was first approved by FDA on Jul 10, 2013, with 7 approved supplements and 0 published complete response letters.

First approved: Jul 10, 2013
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
Jul 10, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Khedezla50MG · tablet, extended release;oral	Desvenlafaxine	Discontinued
Khedezla100MG · tablet, extended release;oral	Desvenlafaxine	Discontinued

All 8 submissions, including labeling and manufacturing supplements


Sep 20, 2021	Supplement 7Labeling · Standard review	Approved	Label Medication Guide Letter
Jan 29, 2019	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 19, 2017	Supplement 5Labeling	Approved	Letter Label
Jan 4, 2017	Supplement 4Labeling	Approved	Letter Label
Sep 6, 2016	Supplement 3Labeling	Approved	Letter Label
Jul 16, 2014	Supplement 2Labeling	Approved	Letter Label
Oct 1, 2013	Supplement 1Labeling · Standard review	Approved	Letter Label
Jul 10, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 204683
Drugs@FDA: Overview at FDA
Company: Osmotica Pharmaceutical

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