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
493410f3-0733-4f76-8050-6529d96f2a5b
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 28, 2022
Manufacturers
FDA
Fresenius Kabi USA, LLC
DUNS: 013547657
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 Code65219-029
Application NumberANDA214222
Product Classification
M
Marketing Category
C73584
G
Generic Name
Thiotepa
Product Specifications
Route of AdministrationINTRAVENOUS, INTRACAVITARY, INTRAVESICAL
Effective DateFebruary 28, 2022
FDA Product Classification
INGREDIENTS (2)
THIOTEPAActive
Quantity: 100 mg in 1 1
Code: 905Z5W3GKH
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT