ANDA 74956, held by Fresenius Kabi USA. Dipyridamole.
As of Nov 15, 2026, ANDA 74956 (Dipyridamole), held by Fresenius Kabi USA, was first approved by FDA on Sep 30, 1998, with 3 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 30, 1998 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Dipyridamole5MG/ML ยท injectable;injection | Dipyridamole | Discontinued |
| Dec 5, 2002 | Supplement 3Manufacturing | Approved | None posted |
| Feb 15, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Aug 21, 2000 | Supplement 1Manufacturing | Approved | None posted |
| Sep 30, 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
