Treats superficial papillary carcinoma of the urinary bladder. ANDA 209150, held by Hengrui Pharma. Thiotepa.
As of Nov 13, 2026, ANDA 209150 (Thiotepa), held by Hengrui Pharma, was first approved by FDA on May 4, 2018, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Thiotepa for Injection has been tried with varying results in the palliation of a wide variety of neoplastic diseases. However, the most consistent results have been seen in the following tumors: Adenocarcinoma of the breast. Adenocarcinoma of the ovary. For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. For the treatment of superficial papillary carcinoma of the urinary bladder. While now largely superseded by other treatments, Thiotepa for Injection has been effective against other lymphomas, such as lymphosarcoma and Hodgkin's disease.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 4, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Thiotepa15MG/VIAL · 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
