NDA 13077, held by Astrazeneca. Lidocaine.
As of Nov 13, 2026, NDA 13077 (Xylocaine), held by Astrazeneca, was first approved by FDA on Mar 6, 1964, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 6, 1964 | Original applicationNew combination · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Xylocaine100MG · suppository;rectal | Lidocaine | 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
