TEPYLUTE (THIOTEPA)
Summary
FDA approved TEPYLUTE (THIOTEPA) by SHORLA. NDA (New Drug) approval (Labeling) on 2025-12-09. SOLUTION, INTRAVENOUS.
Details
Source
Drug Approval
External ID
NDA216984-6
Action Date
2025-12-09
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
TEPYLUTE (generic: THIOTEPA), SOLUTION, INTRAVENOUS. Application: NDA216984
Company
Context & Analysis
SHORLA has 3 FDA actions in our database.
Frequently Asked Questions
How often does SHORLA have FDA actions?
SHORLA has 3 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA216984-6" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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