Relieves pain associated with post-herpetic neuralgia. NDA 20612, held by Teikoku Pharma USA. Lidocaine.
As of Nov 15, 2026, NDA 20612 (Lidoderm), held by Teikoku Pharma USA, was first approved by FDA on Mar 19, 1999, with 8 approved supplements and 0 published complete response letters.
INDICATION AND USAGE LIDOCAINE PATCH 5% is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 19, 1999 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lidoderm5% · patch;topical | Lidocaine | RxReference drug |
| Nov 2, 2018 | Supplement 14Labeling · Standard review | Approved | |
| Mar 17, 2016 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Jan 7, 2015 | Supplement 12Labeling · Standard review | Approved | |
| Apr 13, 2010 | Supplement 11Labeling · Standard review | Approved | |
| Apr 27, 2006 | Supplement 8Labeling · Standard review | Approved | |
| May 5, 2005 | Supplement 7Labeling · Standard review | Approved | |
| Jul 2, 2002 | Supplement 3Manufacturing · Standard review | Approved | |
| May 26, 1999 | Supplement 2Manufacturing · Standard review | Approved | |
| Mar 19, 1999 | 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
