NDA 22466, held by Pierrel. Articaine Hydrochloride; Epinephrine Bitartrate.
As of Nov 15, 2026, NDA 22466 (Orabloc), held by Pierrel, was first approved by FDA on Feb 26, 2010, with 4 approved supplements and 0 published complete response letters.
Articaine HCl and Epinephrine is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures in adults and pediatric patients 4 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 26, 2010 | Original applicationNew combination · Standard review | Approved |
| Orabloc4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG BASE/ML) · injectable;injection | Articaine Hydrochloride; Epinephrine Bitartrate | RxReference drug |
| Orabloc4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG BASE/ML) · injectable;injection | Articaine Hydrochloride; Epinephrine Bitartrate | RxReference drug |
| Jul 2, 2025 | Supplement 9Labeling · Standard review | Approved | |
| Nov 2, 2018 | Supplement 5Labeling · Standard review | Approved | |
| Mar 10, 2014 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Jan 20, 2011 | Supplement 1Labeling | Approved | |
| Feb 26, 2010 | Original applicationNew combination · 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
