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Medicines · US (FDA)

FDA 2024

FDA

Thiotepa

Approved 20 Aug 2024Intracavitary, Intravenous, Into the bladderPowder

The FDA lists this product in 17 strengths and forms.

Official labelAsk Osler about it

On this page

Composition
Strengths and forms
Official product information

The table holds no label text for this product yet, only the facts beside it. The official product information has the full text.

Composition

Active ingredients: THIOTEPA 15MG/VIAL

Strengths and forms

The FDA lists each strength of a product separately; these pages share one label.

THIOTEPA 15MG/VIAL · InjectableANDA210337-001 · Prescription
THIOTEPA 15MG/VIAL · InjectableANDA211831-001 · Prescription
THIOTEPA 15MG/VIAL · InjectableNDA011683-001 · Discontinued
THIOTEPA 15MG/VIAL · InjectableANDA209150-001 · Discontinued
THIOTEPA 100MG/VIAL · PowderANDA213049-002 · Prescription
THIOTEPA 15MG/VIAL · PowderANDA213049-001 · Prescription
THIOTEPA 100MG/VIAL · PowderANDA214222-002 · Prescription
THIOTEPA 15MG/VIAL · PowderANDA214222-001 · Prescription
THIOTEPA 15MG/VIAL · PowderANDA216037-001 · Prescription
THIOTEPA 100MG/VIAL · PowderANDA216037-002 · Prescription
THIOTEPA 15MG/VIAL · InjectableANDA075698-001 · Discontinued
THIOTEPA 15MG/VIAL · InjectableANDA208242-001 · Prescription

Two medicines in one question?

Name two or more medicines and Osler runs an interaction check. A severe interaction is stated at the very top of the answer.

THIOTEPA 15MG/VIAL · InjectableANDA075547-001 · Prescription

THIOTEPA 15MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableANDA075730-001 · Discontinued

THIOTEPA 30MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · InjectableANDA075730-002 · Discontinued

THIOTEPA 15MG/VIAL · PowderThis page

THIOTEPA 100MG/VIAL · PowderANDA211755-001 · Prescription

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA217559.

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Thiotepa
Route: Intracavitary, Intravenous, Into the bladder
Dosage form: Powder
Applicant: Regcon Holdings
Status: Prescription
FDA approval: 20 Aug 2024
Application: ANDA217559-001