Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 80198, held by Fougera Pharms Inc. Lidocaine.
As of Nov 15, 2026, ANDA 80198 (Lidocaine), held by Fougera Pharms Inc, was first approved by FDA on Jun 30, 1972, with 7 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 30, 1972 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Lidocaine5% · ointment;topical | Lidocaine | RxReference drug |
| Nov 2, 2018 | Supplement 30Labeling · Standard review | Approved | None posted |
| Nov 14, 2000 | Supplement 21Manufacturing | Approved | None posted |
| Mar 7, 1996 | Supplement 20Manufacturing | Approved | None posted |
| Nov 20, 1995 | Supplement 19Manufacturing | Approved | None posted |
| May 9, 1988 | Supplement 18Labeling | Approved | |
| Dec 11, 1987 | Supplement 17Manufacturing | Approved | None posted |
| May 9, 1983 | Supplement 15Manufacturing | Approved | None posted |
| Jun 30, 1972 | 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
