ANDA 77041, held by Roxane. Citalopram Hydrobromide.
As of Nov 15, 2026, ANDA 77041 (Citalopram Hydrobromide), held by Roxane, was first approved by FDA on Nov 23, 2004, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 23, 2004 | Original application | Approved | None posted |
| Citalopram HydrobromideEQ 10MG BASE · tablet;oral | Citalopram Hydrobromide | Discontinued |
| Citalopram HydrobromideEQ 20MG BASE · tablet;oral | Citalopram Hydrobromide | Discontinued |
| Citalopram HydrobromideEQ 40MG BASE · tablet;oral | Citalopram Hydrobromide | Discontinued |
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