ANDA 74285, held by Purepac Pharm. Diflunisal.
As of Nov 15, 2026, ANDA 74285 (Diflunisal), held by Purepac Pharm, was first approved by FDA on May 7, 1996, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 7, 1996 | Original application | Approved |
| Diflunisal250MG · tablet;oral | Diflunisal | Discontinued |
| Diflunisal500MG · tablet;oral | Diflunisal | Discontinued |
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
