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TEPADINA

These highlights do not include all the information needed to use TEPADINA® safely and effectively. See full prescribing information for TEPADINA®. TEPADINA® (thiotepa) for injection, for intravenous, intracavitary, or intravesical use. nitial U.S. Approval: 1959 TEPADINA® (thiotepa) for injection, for intravenous, intracavitary, or intravesical use. Initial U.S. Approval: 1959

Approved
Approval ID

559e353c-2dc0-16ba-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 27, 2020

Manufacturers
FDA

Amneal Pharmaceuticals LLC

DUNS: 827748190

Products 3

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 Code70121-2749
Application NumberNDA208264
Product Classification
M
Marketing Category
C73594
G
Generic Name
thiotepa
Product Specifications
Route of AdministrationINTRACAVITARY, INTRAVENOUS, INTRAVESICAL
Effective DateApril 22, 2025
FDA Product Classification

INGREDIENTS (2)

THIOTEPAActive
Quantity: 200 mg in 1 1
Code: 905Z5W3GKH
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 200 mL in 1 1
Code: 451W47IQ8X
Classification: IACT

THIOTEPA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70121-1630
Application NumberNDA208264
Product Classification
M
Marketing Category
C73594
G
Generic Name
THIOTEPA
Product Specifications
Route of AdministrationINTRACAVITARY, INTRAVENOUS, INTRAVESICAL
Effective DateMarch 27, 2020
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 Code70121-1631
Application NumberNDA208264
Product Classification
M
Marketing Category
C73594
G
Generic Name
THIOTEPA
Product Specifications
Route of AdministrationINTRACAVITARY, INTRAVENOUS, INTRAVESICAL
Effective DateMarch 27, 2020
FDA Product Classification

INGREDIENTS (1)

THIOTEPAActive
Quantity: 100 mg in 1 1
Code: 905Z5W3GKH
Classification: ACTIB

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