Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 206297, held by Amneal Pharms. Lidocaine.
As of Nov 15, 2026, ANDA 206297 (Lidocaine), held by Amneal Pharms, was first approved by FDA on Aug 7, 2015, with 5 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 |
|---|---|---|---|
| Aug 7, 2015 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lidocaine5% · ointment;topical | Lidocaine | Rx |
| Nov 2, 2018 | Supplement 8Labeling · Standard review | Approved | None posted |
| Apr 9, 2018 | Supplement 7Labeling · Standard review | Approved | None posted |
| Jun 20, 2017 | Supplement 2Labeling · Standard review | Approved | None posted |
| Jun 20, 2017 | Supplement 3Manufacturing | Approved | None posted |
| Jun 20, 2017 | Supplement 5Manufacturing | Approved | None posted |
| Aug 7, 2015 | 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
