ANDA 77038, held by Dr Reddys Labs Ltd. Citalopram Hydrobromide.
As of Nov 15, 2026, ANDA 77038 (Citalopram Hydrobromide), held by Dr Reddys Labs Ltd, was first approved by FDA on Oct 28, 2004, with 13 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 | Rx |
| Citalopram HydrobromideEQ 20MG BASE · tablet;oral | Citalopram Hydrobromide | Rx |
| Citalopram HydrobromideEQ 40MG BASE · tablet;oral | Citalopram Hydrobromide | Rx |
| Sep 19, 2024 | Supplement 19Labeling · Standard review | Approved | None posted |
| Sep 19, 2024 | Supplement 18Labeling · Standard review | Approved | None posted |
| Sep 19, 2024 | Supplement 17Labeling · Standard review | Approved | None posted |
| Sep 19, 2024 | Supplement 16Labeling · Standard review | Approved | None posted |
| Aug 10, 2015 | Supplement 14Labeling · Standard review | Approved | None posted |
| Aug 10, 2015 | Supplement 11Labeling · Standard review | Approved | None posted |
| Jun 26, 2012 | Supplement 10Labeling · Standard review | Approved | None posted |
| Jun 26, 2012 | Supplement 9Labeling | Approved | None posted |
| Apr 6, 2009 | Supplement 7Labeling | Approved | None posted |
| Jan 22, 2009 | Supplement 6Labeling | Approved | None posted |
| Aug 13, 2008 | Supplement 4Labeling | Approved | None posted |
| Oct 19, 2007 | Supplement 3Labeling | Approved | None posted |
| Apr 27, 2005 | Supplement 1Labeling | 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
