NDA 22172, held by Cheplapharm Arzneimittel GmbH. Quetiapine Fumarate.
As of Nov 13, 2026, NDA 22172 (Seroquel Xr), held by Cheplapharm Arzneimittel GmbH, was first approved by FDA on Nov 15, 2007, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 15, 2007 | Original applicationTYPE 6 · Standard review | Approved |
| Seroquel Xr50MG · tablet, extended release; oral | Quetiapine Fumarate | Rx |
| Seroquel Xr200MG · tablet, extended release; oral | Quetiapine Fumarate | Rx |
| Seroquel Xr300MG · tablet, extended release; oral | Quetiapine Fumarate | Rx |
| Seroquel Xr400MG · tablet, extended release; oral | Quetiapine Fumarate | 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
