NDA 205208, held by Teva Pharms USA. Desvenlafaxine Fumarate.
As of Nov 15, 2026, NDA 205208 (Desvenlafaxine), held by Teva Pharms USA, was first approved by FDA on Oct 11, 2013, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 11, 2013 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| DesvenlafaxineEQ 50MG BASE · tablet, extended release;oral | Desvenlafaxine Fumarate | Discontinued |
| DesvenlafaxineEQ 100MG BASE · tablet, extended release;oral | Desvenlafaxine Fumarate | Discontinued |
| Jul 18, 2014 | Supplement 1Labeling | Approved | |
| Oct 11, 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
