NDA 20962, held by Astrazeneca. Lidocaine; Prilocaine.
As of Nov 13, 2026, NDA 20962 (Emla), held by Astrazeneca, was first approved by FDA on Feb 4, 1998, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 4, 1998 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Emla2.5%;2.5% · disc;topical | Lidocaine; Prilocaine | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 9, 2002 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Feb 15, 2002 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 20, 2000 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 4, 1998 | Original applicationNew dosage form · 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
