NDA 22043, held by Janssen LP. Paliperidone.
As of Nov 14, 2026, NDA 22043 (Invega), held by Janssen LP, was first approved by FDA on Apr 27, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 27, 2007 | Original applicationTYPE 6 · Standard review | Approved |
| Invega3MG · tablet, extended release; oral | Paliperidone | Rx |
| Invega6MG · tablet, extended release; oral | Paliperidone | Rx |
| Invega9MG · tablet, extended release; oral | Paliperidone | Rx |
| Invega12MG · tablet, extended release; oral | Paliperidone | 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