THIOTEPA Pharmacologic Class Indexing
- Class set ID
- 97be42f1-b2bf-4aca-b2ac-26df2bba9243
- Version
- 2
- Effective date
- 20180813
- Type
- Indexing - Pharmacologic Class
Mapped DailyMed Labels#
Label, Manufacturer, Effective table| Label | Manufacturer | Effective | SPL version |
|---|
| These highlights do not include all the information needed to use TEPADINA® safely and effectively. See full prescribing information for TEPADINA®. TEPADINA® (thiotepa) for injection, for intravenous, intracavitary, or intravesical use. Initial U.S. Approval: 1959 | Amneal Pharmaceuticals LLC | Adienne S.r.l. | BSP Pharmaceuticals SpA | CIT SRL | Eurofins Biolab Srl | Indena SpA | LabAnalysis Life Science srl | NerPharMa S.r.l | 20260130 | 30 |
| These highlights do not include all the information needed to use THIOTEPA FOR INJECTION safely and effectively. See full prescribing information for THIOTEPA FOR INJECTION. THIOTEPA for injection, for intravenous, intracavitary, or intravesical use. Initial U.S. Approval: 1959 | Gland Pharma Limited | 20260123 | 7 |
| THIOTEPA FOR INJECTION, USP (For Intravenous, Intracavitary or Intravesical Use) | Sagent Pharmaceuticals | 20251020 | 4 |
| These highlights do not include all the information needed to use TEPYLUTE ® safely and effectively. See full prescribing information for TEPYLUTE ® . TEPYLUTE ® (thiotepa) injection, for intravenous use Initial U.S. Approval: 1959 | Shorla Oncology Inc. | Shorla Pharma Ltd. | AqVida GmbH | 20250701 | 4 |
| These highlights do not include all the information needed to use THIOTEPA FOR INJECTION safely and effectively. See full prescribing information for THIOTEPA FOR INJECTION. THIOTEPA for injection, for intravenous, intracavitary, or intravesical use. Initial U.S. Approval: 1959 | Novadoz Pharmaceuticals LLC | MSN LABORATORIES PRIVATE LIMITED | 20240414 | 2 |
| These highlights do not include all the information needed to use THIOTEPA FOR INJECTION safely and effectively. See full prescribing information for THIOTEPA FOR INJECTION. THIOTEPA for injection, for intravenous, intracavitary, or intravesical use Initial U.S. Approval: 1959 | Meitheal Pharmaceuticals Inc | Kindos Pharmaceuticals Co., Ltd. | 20231227 | 4 |
| These highlights do not include all the information needed to use THIOTEPA FOR INJECTION safely and effectively. See full prescribing information for THIOTEPA FOR INJECTION. THIOTEPA for injection, for intravenous, intracavitary, or intravesical use. Initial U.S. Approval: 1959 | Hikma Pharmaceuticals USA Inc. | 20230531 | 3 |
| THIOTEPA FOR INJECTION, USP | Hikma Pharmaceuticals USA Inc. | 20230524 | 4 |
| These highlights do not include all the information needed to use THIOTEPA FOR INJECTION safely and effectively. See full prescribing information for THIOTEPA FOR INJECTION. THIOTEPA for injection , for intravenous, intracavitary, or intravesical use. Initial U.S. Approval: 1959 | Dr.Reddy's Laboratories Inc., | Gland Pharma Ltd | 20221101 | 2 |
| These highlights do not include all the information needed to use THIOTEPA FOR INJECTION safely and effectively. See full prescribing information for THIOTEPA FOR INJECTION. THIOTEPA for injection, for intravenous, intracavitary, or intravesical use. Initial U.S. Approval: 1959 | Fresenius Kabi USA, LLC | Gland Pharma Limited | 20220328 | 1 |
| THIOTEPA FOR INJECTION, USP | Hikma Pharmaceuticals USA Inc. | 20210402 | 6 |
| Thiotepa for Injection | Dr.Reddy's Laboratories Inc., | Gland Pharma Ltd | 20180425 | 7 |