ANDA 203547, held by Zydus Pharms. Diflunisal.
As of Nov 15, 2026, ANDA 203547 (Diflunisal), held by Zydus Pharms, was first approved by FDA on Jun 16, 2017, with 2 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Carefully consider the potential benefits and risks of diflunisal tablets and other treatment options before deciding to use diflunisal tablets. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see WARNINGS ). Diflunisal tablets are indicated for acute or long-term use for symptomatic treatment of the following: 1. Mild to moderate pain 2. Osteoarthritis 3. Rheumatoid arthritis
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 16, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Diflunisal500MG · tablet;oral | Diflunisal | Rx |
| Nov 21, 2024 | Supplement 2Labeling · Standard review | Approved | None posted |
| Apr 28, 2021 | Supplement 1Labeling · Standard review | Approved | None posted |
| Jun 16, 2017 | 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
