NDA 22033, held by Jazz Pharms. Fluvoxamine Maleate.
As of Nov 14, 2026, NDA 22033 (Luvox Cr), held by Jazz Pharms, was first approved by FDA on Feb 28, 2008, with 7 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2008 | Original applicationNew dosage form · Standard review | Approved |
| Luvox Cr100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, extended release;oral | Fluvoxamine Maleate | DiscontinuedReference drug |
| Luvox Cr150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule, extended release;oral | Fluvoxamine Maleate | DiscontinuedReference drug |
| Jan 4, 2017 | Supplement 11Labeling | Approved | |
| Jul 18, 2014 | Supplement 10Labeling | Approved | |
| Nov 30, 2012 | Supplement 9Labeling · Standard review | Approved | |
| May 9, 2011 | Supplement 3Labeling · Standard review | Approved | |
| May 9, 2011 | Supplement 6Labeling · Standard review | Approved | |
| May 9, 2011 | Supplement 7Labeling · Standard review | Approved | |
| Feb 24, 2009 | Supplement 2Labeling · Standard review | Approved | |
| Feb 28, 2008 | 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
