Treats acute pain due to minor strains, sprains, and contusions. NDA 206976, held by Ibsa Inst Bio. Diclofenac Epolamine.
As of Nov 14, 2026, NDA 206976 (Licart), held by Ibsa Inst Bio, was first approved by FDA on Dec 19, 2018, with 6 approved supplements and 1 published complete response letter.
LICART is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.
| Mar 27, 2026 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Dec 19, 2018 | Original applicationTYPE 3/4 · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Mar 24, 2017 | Diclofenac epolamineClinical, Nonclinical, Product Quality | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Licart1.3% · system;topical | Diclofenac Epolamine | RxReference drug |
| Mar 27, 2026 | Supplement 18Efficacy (new indication or use) · Standard review | Approved | |
| Nov 21, 2024 | Supplement 16Labeling · Standard review | Approved | |
| May 23, 2024 | Supplement 15Manufacturing | Approved | |
| Apr 28, 2021 | Supplement 7Labeling · Standard review | Approved | |
| May 14, 2020 | Supplement 2Labeling · Standard review | Approved | |
| Jan 13, 2020 | Supplement 3Labeling · Standard review | Approved | |
| Dec 19, 2018 | Original applicationTYPE 3/4 · Standard review | 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
