ANDA 75730, held by Teva Parenteral. Thiotepa.
As of Nov 13, 2026, ANDA 75730 (Thiotepa), held by Teva Parenteral, was first approved by FDA on Apr 20, 2001, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 20, 2001 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thiotepa15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Thiotepa | Discontinued |
| Thiotepa30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · injectable;injection | Thiotepa | Discontinued |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
