thiotepa
thiotepa is listed in the FDA National Drug Code directory with 4 NDC codes, marketed under brand names including TEPADINA, TEPYLUTE. Available dosage forms: injection, powder, lyophilized, for solution, injection.
Drug Details
- Generic Name
- thiotepa
- Brand Names
- TEPADINA, TEPYLUTE
- Application Number
- NDA208264
- Sponsor
- Amneal Pharmaceuticals LLC
- NDC Codes
- 4
- Dosage Forms
- INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, INJECTION
- Routes
- INTRACAVITARY, INTRAVENOUS, INTRAVESICAL
- Active Ingredients
- THIOTEPA
Indications and Usage
1 INDICATIONS AND USAGE Thiotepa for Injection is an alkylating drug indicated: For treatment of adenocarcinoma of the breast or ovary. ( 1.2 ) For controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. ( 1.3 ) For treatment of superficial papillary carcinoma of the urinary bladder. ( 1.4 ) 1.2 Adenocarcinoma of the Breast or Ovary Thiotepa for Injection is indicated for treatment of adenocarcinoma of the breast or ovary. 1.3 Malignant Effusions Thiotepa for Injection is indicated for controlling intracavitary effusions secondary to diffuse or localized neoplastic diseases of various serosal cavities. 1.4 Superficial Papillary Carcinoma of the Urinary Bladder Thiotepa for Injection is indicated for treatment of superficial papillary carcinoma of the urinary bladder. Pediatric use information is approved for Adienne SA’s TEPADINA (thiotepa) for injection. However, due to Adienne SA’s marketing exclusivity rights, the drug product is not labeled with that information.