NDA 19941, held by Teva Branded Pharm. Lidocaine; Prilocaine.
As of Nov 13, 2026, NDA 19941 (Emla), held by Teva Branded Pharm, was first approved by FDA on Dec 30, 1992, with 16 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 28, 2000 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 11, 1999 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 1998 | Supplement 8Efficacy (new indication or use) | Approved | |
| Dec 30, 1992 | Original applicationNew dosage form · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Emla2.5%;2.5% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · cream;topical | Lidocaine; Prilocaine | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 2, 2018 | Supplement 21Labeling · Standard review | Approved | |
| Jan 25, 2013 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Apr 27, 2006 | Supplement 18Labeling · Standard review | Approved | |
| Dec 19, 2005 | Supplement 17Labeling · Standard review | Approved | |
| Jan 27, 2003 | Supplement 15Manufacturing · Standard review | Approved | |
| Jun 2, 2000 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Apr 20, 2000 | Supplement 12Labeling · Standard review | Approved | |
| Jan 28, 2000 | Supplement 11Efficacy (new indication or use) · Standard review | Approved | |
| Mar 11, 1999 | Supplement 10Efficacy (new indication or use) · Standard review | Approved | |
| Feb 4, 1998 | Supplement 9Labeling · Standard review | Approved | |
| Feb 4, 1998 | Supplement 8Efficacy (new indication or use) | Approved | |
| Feb 4, 1998 | Supplement 7Labeling · Standard review | Approved | |
| May 31, 1996 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| May 31, 1996 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| Sep 27, 1995 | Supplement 3Manufacturing · Standard review | Approved | None posted |
| Apr 11, 1994 | Supplement 2Labeling · Standard review | Approved | |
| Dec 30, 1992 | Original applicationNew dosage form · Standard review | Approved | None posted |
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
