ANDA 75199, held by Ani Pharms. Pentoxifylline.
As of Nov 13, 2026, ANDA 75199 (Pentoxifylline), held by Ani Pharms, was first approved by FDA on Sep 3, 1999, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pentoxifylline400MG · tablet, extended release;oral | Pentoxifylline | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 2, 2015 | Supplement 3Labeling · Standard review | Approved | None posted |
| Sep 3, 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
