NDA 22010, held by Deproco. Articaine Hydrochloride; Epinephrine Bitartrate.
As of Nov 13, 2026, NDA 22010 (Septocaine), held by Deproco, was first approved by FDA on Mar 30, 2006, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 30, 2006 | Original applicationNew formulation or manufacturer · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Septocaine4%;EQ 0.0085MG BASE/1.7ML (4%;EQ 0.005MG BASE/ML) · injectable;injection | Articaine Hydrochloride; Epinephrine Bitartrate | RxReference 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
