NDA 21763, held by Biovail Labs Intl. Citalopram Hydrobromide.
As of Nov 14, 2026, NDA 21763 (Citalopram Hydrobromide), held by Biovail Labs Intl, was first approved by FDA on Dec 20, 2005, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 20, 2005 | Original applicationNew dosage form · Standard review | Approved |
| Citalopram HydrobromideEQ 10MG BASE · tablet, orally disintegrating;oral | Citalopram Hydrobromide | DiscontinuedReference drug |
| Citalopram HydrobromideEQ 20MG BASE · tablet, orally disintegrating;oral | Citalopram Hydrobromide | DiscontinuedReference drug |
| Citalopram HydrobromideEQ 40MG BASE · tablet, orally disintegrating;oral | Citalopram Hydrobromide | DiscontinuedReference drug |
| Citalopram Hydrobromide40MG · tablet; orally disintegrating | Citalopram Hydrobromide | 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
