Thiotepa
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
Approved
Approval ID
9ae8063c-ba28-4da2-a94c-8e1a5f75e4b3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 31, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 001230762
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Thiotepa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0143-9292
Application NumberANDA211755
Product Classification
M
Marketing Category
C73584
G
Generic Name
Thiotepa
Product Specifications
Route of AdministrationINTRACAVITARY, INTRAVENOUS, INTRAVESICAL
Effective DateSeptember 8, 2023
FDA Product Classification
INGREDIENTS (2)
THIOTEPAActive
Quantity: 100 mg in 1 1
Code: 905Z5W3GKH
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT