NDA 22351, held by Ar Holding Co Inc. Colchicine.
As of Nov 13, 2026, NDA 22351 (Colcrys), held by Ar Holding Co Inc, was first approved by FDA on Jul 30, 2009, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 30, 2009 | Original applicationTYPE 7 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Colcrys0.6MG · tablet; oral | Colchicine | Rx |
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
