NDA 21123, held by Janssen Pharms. Acetaminophen; Tramadol Hydrochloride.
As of Nov 13, 2026, NDA 21123 (Ultracet), held by Janssen Pharms, was first approved by FDA on Aug 15, 2001, with 14 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2001 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Ultracet325MG;37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet;oral | Acetaminophen; Tramadol Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 13, 2023 | Supplement 15Labeling · Standard review | Approved | |
| Sep 10, 2021 | Supplement 21Labeling · Standard review | Approved | |
| Mar 4, 2021 | Supplement 20Labeling · Standard review | Approved | |
| Oct 7, 2019 | Supplement 19Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 17Labeling · Standard review | Approved | |
| Sep 18, 2018 | Supplement 16REMS | Approved | |
| Aug 29, 2017 | Supplement 14Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 13Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 12Labeling · Standard review | Approved | |
| Dec 16, 2016 | Supplement 10Labeling · Standard review | Approved | |
| Oct 18, 2013 | Supplement 8Labeling | Approved | |
| Jun 22, 2011 | Supplement 5Labeling | Approved | |
| Sep 9, 2009 | Supplement 3Labeling · Standard review | Approved | |
| Apr 16, 2004 | Supplement 1Labeling · Standard review | Approved | |
| Aug 15, 2001 | Original applicationNew combination · 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
