Treats major depressive disorder (MDD). ANDA 77534, held by Invagen Pharms. Citalopram Hydrobromide.
As of Nov 15, 2026, ANDA 77534 (Citalopram Hydrobromide), held by Invagen Pharms, was first approved by FDA on Oct 3, 2006, with 12 approved supplements and 0 published complete response letters.
Citalopram is indicated for the treatment of major depressive disorder (MDD) in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 3, 2006 | Original application | Approved | None posted |
| Citalopram HydrobromideEQ 10MG BASE · tablet;oral | Citalopram Hydrobromide | Rx |
| Citalopram HydrobromideEQ 20MG BASE · tablet;oral | Citalopram Hydrobromide | Rx |
| Citalopram HydrobromideEQ 40MG BASE · tablet;oral | Citalopram Hydrobromide | Rx |
| Sep 18, 2024 | Supplement 25Labeling · Standard review | Approved | None posted |
| Apr 16, 2024 | Supplement 24Labeling · Standard review | Approved | None posted |
| Nov 21, 2022 | Supplement 14Labeling · Standard review | Approved | None posted |
| Nov 21, 2022 | Supplement 17Labeling · Standard review | Approved | None posted |
| Nov 21, 2022 | Supplement 19Labeling · Standard review | Approved | None posted |
| Nov 21, 2022 | Supplement 20Labeling · Standard review | Approved | None posted |
| Mar 9, 2015 | Supplement 9Labeling · Standard review | Approved | None posted |
| Mar 9, 2015 | Supplement 10Labeling · Standard review | Approved | None posted |
| Apr 26, 2013 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 25, 2012 | Supplement 4Labeling | Approved | None posted |
| Aug 21, 2009 | Supplement 2Labeling | Approved | None posted |
| Jun 28, 2007 | Supplement 1Labeling | Approved | None posted |
| Oct 3, 2006 | 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
