Thiotepa
Thiotepa for Injection, USP
Approved
Approval ID
69b6261a-f39d-475e-9613-1607dbbc956f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 15, 2022
Manufacturers
FDA
Athenex Pharmaceutical Division, LLC.
DUNS: 080318964
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 Code70860-220
Application NumberANDA211831
Product Classification
M
Marketing Category
C73584
G
Generic Name
thiotepa
Product Specifications
Route of AdministrationINTRAVENOUS, INTRACAVITARY, INTRAVESICAL
Effective DateOctober 15, 2022
FDA Product Classification
INGREDIENTS (1)
thiotepaActive
Quantity: 15 mg in 1.5 mL
Code: 905Z5W3GKH
Classification: ACTIB