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TEPYLUTE

NDA · New Drug Application · Sponsor: SHORLA · Approved 2024-06-25

Drug application

FDA Application #

NDA216984

Application type

New Drug Application

Brand name

TEPYLUTE

Generic name

THIOTEPA

Active ingredients

THIOTEPA

Dosage form

SOLUTION

Route

INTRAVENOUS

Marketing status

Prescription

Sponsor

SHORLA

Manufacturer

Shorla Oncology Inc.

First approval

2024-06-25

Source

Authoritative

Drugs@FDA application overview

Machine

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