NDA 218643, held by Thea Pharma. Articaine Hydrochloride.
As of Nov 14, 2026, NDA 218643 (Cyklx), held by Thea Pharma, was first approved by FDA on Aug 15, 2025, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 15, 2025 | Original applicationTYPE 3/4 · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| CyklxEQ 8% BASE · solution/drops;ophthalmic | Articaine Hydrochloride | DiscontinuedReference drug |
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
