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 useInitial U.S. Approval: 1959
Approved
Approval ID
4b4725eb-95f1-45cc-852f-152beb5f1e2c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Meitheal Pharmaceuticals Inc
DUNS: 080548348
Products 2
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 Code71288-156
Application NumberANDA216037
Product Classification
M
Marketing Category
C73584
G
Generic Name
Thiotepa
Product Specifications
Route of AdministrationINTRAVENOUS, INTRACAVITARY, INTRAVESICAL
Effective DateFebruary 2, 2023
FDA Product Classification
INGREDIENTS (1)
THIOTEPAActive
Quantity: 15 mg in 1 1
Code: 905Z5W3GKH
Classification: ACTIB
Thiotepa
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71288-157
Application NumberANDA216037
Product Classification
M
Marketing Category
C73584
G
Generic Name
Thiotepa
Product Specifications
Route of AdministrationINTRAVENOUS, INTRACAVITARY, INTRAVESICAL
Effective DateFebruary 2, 2023
FDA Product Classification
INGREDIENTS (1)
THIOTEPAActive
Quantity: 100 mg in 1 1
Code: 905Z5W3GKH
Classification: ACTIB