NDA 21046, held by Forest Labs. Citalopram Hydrobromide.
As of Nov 14, 2026, NDA 21046 (Celexa), held by Forest Labs, was first approved by FDA on Dec 22, 1999, with 12 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 1999 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CelexaEQ 10MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · solution;oral | Citalopram Hydrobromide | DiscontinuedReference drug |
| Dec 3, 2012 | Supplement 20Labeling · Standard review | Approved | |
| Mar 27, 2012 | Supplement 19Labeling · Standard review | Approved | |
| Aug 12, 2011 | Supplement 16Labeling · Standard review | Approved | |
| Aug 12, 2011 | Supplement 17Labeling | Approved | |
| Jan 30, 2009 | Supplement 15Labeling · Standard review | Approved | |
| Sep 18, 2008 | Supplement 14Labeling · Standard review | Approved | |
| Aug 2, 2007 | Supplement 13Labeling · Standard review | Approved | |
| Feb 18, 2005 | Supplement 9Labeling · Standard review | Approved | |
| May 20, 2004 | Supplement 7Labeling · Standard review | Approved | |
| Apr 8, 2004 | Supplement 5Labeling · Standard review | Approved | |
| Nov 19, 2002 | Supplement 3Labeling · Standard review | Approved | |
| Dec 1, 2000 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Dec 22, 1999 | Original applicationNew dosage form · Standard review | 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
