Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 211697, held by Macleods Pharms. Lidocaine.
As of Nov 15, 2026, ANDA 211697 (Lidocaine), held by Macleods Pharms, was first approved by FDA on Mar 16, 2020, with 0 approved supplements 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 16, 2020 | 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
