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
b702dcc9-dd0e-4386-b1e2-f20562fd2ad9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 14, 2024
Manufacturers
FDA
Novadoz Pharmaceuticals LLC
DUNS: 081109687
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 Code72205-045
Application NumberANDA213049
Product Classification
M
Marketing Category
C73584
G
Generic Name
Thiotepa
Product Specifications
Route of AdministrationINTRAVENOUS, INTRACAVITARY, INTRAVESICAL
Effective DateApril 14, 2024
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 Code72205-046
Application NumberANDA213049
Product Classification
M
Marketing Category
C73584
G
Generic Name
Thiotepa
Product Specifications
Route of AdministrationINTRAVENOUS, INTRACAVITARY, INTRAVESICAL
Effective DateApril 14, 2024
FDA Product Classification
INGREDIENTS (1)
THIOTEPAActive
Quantity: 100 mg in 1 1
Code: 905Z5W3GKH
Classification: ACTIB
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/4/2024
BOXED WARNING SECTION
LOINC: 34066-1Updated: 4/4/2024
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/4/2024
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/4/2024
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 4/4/2024
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/4/2024
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 4/4/2024
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/4/2024
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 4/4/2024
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 4/4/2024
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/4/2024
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/4/2024
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/4/2024
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 4/4/2024
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 4/4/2024
REFERENCES SECTION
LOINC: 34093-5Updated: 4/4/2024
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/4/2024
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 4/4/2024