Treats major depressive disorder (MDD). NDA 204150, held by Alembic Pharms Ltd. Desvenlafaxine.
As of Nov 13, 2026, NDA 204150 (Desvenlafaxine), held by Alembic Pharms Ltd, was first approved by FDA on Mar 4, 2013, with 9 approved supplements and 0 published complete response letters.
Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 4, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Desvenlafaxine50MG · tablet, extended release;oral | Desvenlafaxine | RxReference drug |
| Desvenlafaxine100MG · tablet, extended release;oral | Desvenlafaxine | RxReference drug |
| Aug 18, 2023 | Supplement 20Labeling · Standard review | Approved | |
| Sep 20, 2021 | Supplement 18Labeling · Standard review | Approved | |
| Oct 29, 2019 | Supplement 10Labeling · Standard review | Approved | |
| Dec 19, 2017 | Supplement 7Labeling | Approved | |
| Jan 4, 2017 | Supplement 5Labeling | Approved | |
| Sep 9, 2016 | Supplement 4Labeling | Approved | |
| May 15, 2015 | Supplement 3Labeling · Standard review | Approved | |
| Jul 7, 2014 | Supplement 1Labeling · Standard review | Approved | |
| Jul 7, 2014 | Supplement 2Labeling | Approved | |
| Mar 4, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
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
