NDA 50751, held by Den-Mat. Doxycycline Hyclate.
As of Nov 13, 2026, NDA 50751 (Atridox), held by Den-Mat, was first approved by FDA on Sep 3, 1998, with 11 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Atridox50MG · system, extended release;periodontal | Doxycycline Hyclate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 23, 2015 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Apr 21, 2014 | Supplement 19Manufacturing · Standard review | Approved | None posted |
| Feb 14, 2011 | Supplement 15Labeling | Approved | |
| May 20, 2009 | Supplement 13Manufacturing | Approved | |
| Jun 20, 2003 | Supplement 11Manufacturing · Standard review | Approved | |
| Mar 16, 2003 | Supplement 9Labeling · Standard review | Approved | |
| Feb 25, 2000 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Mar 26, 1999 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Mar 11, 1999 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Oct 16, 1998 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Oct 2, 1998 | Supplement 1Manufacturing · Standard review | Approved | None posted |
| Sep 3, 1998 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
