Sold as Thiotepa, Thioplex, Tepadina, Tepadina And Sodium Chloride, Tepylute. Every FDA application for this active ingredient: 4 branded and 12 generic.
As of Nov 13, 2026, FDA lists 16 applications for Thiotepa (sold as Thiotepa, Thioplex, Tepadina and others), first approved Mar 9, 1959, with 0 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Thiotepa | Part B | $46K | -74% | 21 |
| TEPADINA(J9342) | Part B | $36K | New | 21 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 9, 1959 | ThiotepaNDA 11683 · New molecular entity | Immunex | 9 | Discontinued |
| Dec 22, 1994 | ThioplexNDA 20058 · New dosage form | Immunex | 10 | Discontinued |
| Apr 2, 2001 | ThiotepaANDA 75547 | West-Ward Pharms Int | 1 | Marketed |
| Apr 20, 2001 | ThiotepaANDA 75730 | Teva Parenteral | 0 | Discontinued |
| Sep 20, 2001 | ThiotepaANDA 75698 | Fresenius Kabi USA | 4 | Discontinued |
| Jan 26, 2017 | Tepadina, Tepadina And Sodium ChlorideNDA 208264 · New formulation or manufacturer | Adienne SA | 5 | Marketed |
| May 4, 2018 | ThiotepaANDA 209150 | Hengrui Pharma | 0 | Discontinued |
| May 4, 2018 | ThiotepaANDA 210337 | Dr Reddys | 0 | Marketed |
| Jan 10, 2020 | ThiotepaANDA 208242 | Penn Life | 0 | Marketed |
| Mar 4, 2020 | ThiotepaANDA 213049 | Msn | 1 | Marketed |
| Mar 8, 2021 | ThiotepaANDA 214222 | Gland | 1 | Marketed |
| Dec 8, 2021 | ThiotepaANDA 211831 | Regcon Holdings | 0 | Marketed |
| Sep 5, 2023 | ThiotepaANDA 211755 | Hikma | 0 | Marketed |
| Dec 26, 2023 | ThiotepaANDA 216037 | Meitheal | 0 | Marketed |
| Jun 25, 2024 | TepyluteNDA 216984 · New dosage form | Shorla | 3 | Discontinued |
| Aug 20, 2024 | ThiotepaANDA 217559 | Regcon Holdings | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
