ANDA 75093, held by Impax Labs. Pentoxifylline.
As of Nov 13, 2026, ANDA 75093 (Pentoxifylline), held by Impax Labs, was first approved by FDA on Aug 10, 1999, with 2 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pentoxifylline400MG ยท tablet, extended release;oral | Pentoxifylline | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 28, 2000 | Supplement 2Manufacturing | Approved | None posted |
| May 9, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Aug 10, 1999 | 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
