NDA 21496, held by Amphastar Pharms Inc. Bupivacaine Hydrochloride; Lidocaine Hydrochloride.
As of Nov 14, 2026, NDA 21496 (Duocaine), held by Amphastar Pharms Inc, was first approved by FDA on May 23, 2003, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 23, 2003 | Original applicationNew combination · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| DuocaineEQ 0.375% (37.5MG/10ML);EQ 1% (100MG/10ML) · injectable;injection | Bupivacaine Hydrochloride; Lidocaine Hydrochloride | Discontinued |
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
