Relieves pain associated with post-herpetic neuralgia. ANDA 200675, held by Actavis Labs Ut Inc. Lidocaine.
As of Nov 15, 2026, ANDA 200675 (Lidocaine), held by Actavis Labs Ut Inc, was first approved by FDA on Aug 23, 2012, with 0 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 |
|---|---|---|---|
| Aug 23, 2012 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lidocaine5% · patch;topical | Lidocaine | Rx |
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
