Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 210958, held by Strides Pharma. Lidocaine.
As of Nov 15, 2026, ANDA 210958 (Lidocaine), held by Strides Pharma, was first approved by FDA on Dec 11, 2018, 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 |
|---|---|---|---|
| Dec 11, 2018 | 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
