← FDA DRUG APPROVALS

FDA NDA · NDA216984

TEPYLUTE

thiotepa

Sponsor: SHORLA

APPLICATION
NDA216984
TYPE
NDA
ORIGINAL APPROVAL
2024-06-25
LATEST ACTION
2025-12-09
ROUTE
INTRAVENOUS
DOSAGE FORM
SOLUTION
MARKETING STATUS
Prescription

Products

TEPYLUTE · ReferencePrescription
THIOTEPA 15MG/1.5ML (10MG/ML) · SOLUTION · INTRAVENOUS
TEPYLUTE · ReferencePrescription
THIOTEPA 100MG/10ML (10MG/ML) · SOLUTION · INTRAVENOUS

Approval history

2025-12-09Labeling · Supplement 6 · standardAP
2025-12-09Labeling · Supplement 5 · standard — Label ↗AP
2025-02-26Manufacturing (CMC) · Supplement 1 — Label ↗AP
2024-06-25Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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