NDA 21440, held by Forest Labs. Escitalopram Oxalate.
As of Nov 14, 2026, NDA 21440 (Lexapro), held by Forest Labs, was first approved by FDA on Aug 29, 2002, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 29, 2002 | Original applicationTYPE 6 · Standard review | Approved |
| LexaproEQ 5MG BASE · tablet; oral | Escitalopram Oxalate | Rx |
| LexaproEQ 10MG BASE · tablet; oral | Escitalopram Oxalate | Rx |
| LexaproEQ 20MG BASE · tablet; oral | Escitalopram Oxalate | Rx |
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
