Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 217117, held by Aurobindo Pharma Ltd. Lidocaine.
As of Nov 15, 2026, ANDA 217117 (Lidocaine), held by Aurobindo Pharma Ltd, was first approved by FDA on Jun 18, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND 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 |
|---|---|---|---|
| Jun 18, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lidocaine5% · ointment;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
