ANDA 75107, held by Ani Pharms. Pentoxifylline.
As of Nov 13, 2026, ANDA 75107 (Pentoxifylline), held by Ani Pharms, was first approved by FDA on Sep 4, 1998, with 4 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 4, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pentoxifylline400MG ยท tablet, extended release;oral | Pentoxifylline | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 7, 2002 | Supplement 4Manufacturing | Approved | None posted |
| Aug 31, 2001 | Supplement 3Manufacturing | Approved | None posted |
| Mar 22, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Mar 22, 1999 | Supplement 2Manufacturing | Approved | None posted |
| Sep 4, 1998 | 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
