ANDA 217559, held by Regcon Holdings. Thiotepa.
As of Nov 13, 2026, ANDA 217559 (Thiotepa), held by Regcon Holdings, was first approved by FDA on Aug 20, 2024, with 0 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 20, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thiotepa15MG/VIAL ยท powder;intracavitary, intravenous, intravesical | Thiotepa | Rx |
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
