Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 205318, held by Encube. Lidocaine.
As of Nov 15, 2026, ANDA 205318 (Lidocaine), held by Encube, was first approved by FDA on Feb 1, 2016, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Lidocaine Ointment USP, 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 1, 2016 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lidocaine5% · ointment;topical | Lidocaine | Rx |
| Nov 2, 2018 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jul 17, 2017 | Supplement 1Manufacturing | Approved | None posted |
| Feb 1, 2016 | Original application | 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
