Relieves pain associated with post-herpetic neuralgia. ANDA 216484, held by Alkem Labs Ltd. Lidocaine.
As of Nov 15, 2026, ANDA 216484 (Lidocaine), held by Alkem Labs Ltd, was first approved by FDA on Oct 6, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS & 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 |
|---|---|---|---|
| Oct 6, 2025 | Original application | Approved | None posted |
| 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
