ANDA 77048, held by Cosette Pharms Nc. Citalopram Hydrobromide.
As of Nov 15, 2026, ANDA 77048 (Citalopram Hydrobromide), held by Cosette Pharms Nc, was first approved by FDA on Nov 16, 2004, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 16, 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 |
| Dec 16, 2024 | Supplement 26Labeling · Standard review | Approved | None posted |
| Dec 16, 2024 | Supplement 23Labeling · Standard review | Approved | None posted |
| Apr 23, 2013 | Supplement 19Labeling · Standard review | Approved | None posted |
| Dec 19, 2012 | Supplement 18Labeling · Standard review | Approved | None posted |
| Apr 26, 2012 | Supplement 17Labeling | Approved | None posted |
| Apr 2, 2009 | Supplement 14Labeling | Approved | None posted |
| Apr 2, 2009 | Supplement 13Labeling | Approved | None posted |
| Jan 6, 2009 | Supplement 12Labeling | Approved | None posted |
| Apr 3, 2008 | Supplement 9Labeling | Approved | None posted |
| Jul 2, 2007 | Supplement 8Labeling | Approved | None posted |
| Dec 14, 2005 | Supplement 3Labeling | Approved | None posted |
| Jun 9, 2005 | Supplement 2Labeling | Approved | None posted |
| Nov 16, 2004 | Original application | Approved | None posted |
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
