NDA 22331, held by Concordia Pharms Inc. Clonidine Hydrochloride.
As of Nov 13, 2026, NDA 22331 (Jenloga, Kapvay), held by Concordia Pharms Inc, was first approved by FDA on Sep 29, 2009, with 10 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 20, 2014 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2010 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2010 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 29, 2009 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Jenloga0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Clonidine Hydrochloride | DiscontinuedReference drug |
| Jenloga0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Clonidine Hydrochloride | DiscontinuedReference drug |
| Kapvay0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Clonidine Hydrochloride | DiscontinuedReference drug |
| Kapvay0.2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · tablet, extended release;oral | Clonidine Hydrochloride | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 6, 2020 | Supplement 21Labeling · Standard review | Approved | |
| Aug 16, 2016 | Supplement 13Labeling · Standard review | Approved | |
| Jul 20, 2016 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| May 3, 2016 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Jun 5, 2015 | Supplement 15Labeling · Standard review | Approved | |
| Nov 20, 2014 | Supplement 14Efficacy (new indication or use) · Standard review | Approved | |
| Feb 12, 2013 | Supplement 12Labeling · Standard review | Approved | |
| Sep 28, 2010 | Supplement 1Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2010 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Sep 28, 2010 | Supplement 5Labeling · Standard review | Approved | |
| Sep 29, 2009 | 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
