Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 206498, held by Glenmark Pharms Ltd. Lidocaine.
As of Nov 15, 2026, ANDA 206498 (Lidocaine), held by Glenmark Pharms Ltd, was first approved by FDA on Sep 9, 2016, with 1 approved supplement and 0 published complete response letters.
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 |
|---|---|---|---|
| Sep 9, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lidocaine5% · ointment;topical | Lidocaine | Rx |
| Nov 2, 2018 | Supplement 2Labeling · Standard review | Approved | None posted |
| Sep 9, 2016 | 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
