Treats major depressive disorder (MDD). ANDA 77045, held by Epic Pharma. Citalopram Hydrobromide.
As of Nov 15, 2026, ANDA 77045 (Citalopram Hydrobromide), held by Epic Pharma, was first approved by FDA on Apr 29, 2005, with 7 approved supplements and 0 published complete response letters.
Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 29, 2005 | Original application | Approved | None posted |
| Citalopram HydrobromideEQ 40MG BASE · tablet;oral | Citalopram Hydrobromide | Rx |
| Citalopram HydrobromideEQ 20MG BASE · tablet;oral | Citalopram Hydrobromide | Rx |
| Citalopram HydrobromideEQ 10MG BASE · tablet;oral | Citalopram Hydrobromide | Rx |
| Nov 14, 2024 | Supplement 8Labeling · Standard review | Approved | None posted |
| Nov 14, 2024 | Supplement 14Labeling · Standard review | Approved | None posted |
| Nov 14, 2024 | Supplement 15Labeling · Standard review | Approved | None posted |
| Nov 14, 2024 | Supplement 17Labeling · Standard review | Approved | None posted |
| Nov 24, 2014 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 24, 2014 | Supplement 4Labeling · Standard review | Approved | None posted |
| Nov 24, 2014 | Supplement 6Labeling · Standard review | Approved | None posted |
| Apr 29, 2005 | 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
