ANDA 77033, held by Heritage Pharma. Citalopram Hydrobromide.
As of Nov 15, 2026, ANDA 77033 (Citalopram Hydrobromide), held by Heritage Pharma, was first approved by FDA on Oct 28, 2004, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 28, 2004 | Original application | Approved |
| 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 |
| Sep 18, 2024 | Supplement 11Labeling · Standard review | Approved | None posted |
| Sep 18, 2024 | Supplement 12Labeling · Standard review | Approved | None posted |
| Feb 6, 2006 | Supplement 4Labeling | Approved | None posted |
| Oct 28, 2004 | Original application | Approved |
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
