Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 207810, held by Alkem Labs Ltd. Lidocaine.
As of Nov 15, 2026, ANDA 207810 (Lidocaine), held by Alkem Labs Ltd, was first approved by FDA on Mar 10, 2017, with 1 approved supplement and 0 published complete response letters.
INDICATIONS & USAGE Lidocaine Ointment 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 |
|---|---|---|---|
| Mar 10, 2017 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lidocaine5% · ointment;topical | Lidocaine | Rx |
| Nov 2, 2018 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 10, 2017 | Original application | 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
