Thiotepa
Thiotepa for Injection, USP
Approved
Approval ID
7f931b7f-207b-4160-a784-984e5280546f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 17, 2022
Manufacturers
FDA
STI Pharma LLC
DUNS: 832714070
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 Code54879-014
Application NumberANDA208242
Product Classification
M
Marketing Category
C73584
G
Generic Name
Thiotepa
Product Specifications
Route of AdministrationINTRACAVITARY, INTRAVESICAL, INTRAVENOUS
Effective DateNovember 17, 2022
FDA Product Classification
INGREDIENTS (1)
THIOTEPAActive
Quantity: 15 mg in 15 mg
Code: 905Z5W3GKH
Classification: ACTIB