Orange Book product · Brand (NDA)

TEPADINA AND SODIUM CHLORIDE

THIOTEPA

Brand (NDA)NDA 208264RX ADIENNE SA

Apr 10, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 10, 2025
1 yr 3 mo ago
Today
Patent 9931458 expires
Listed drug product patent expiration.
May 31, 2037
in 11 yr 1 mo

Active ingredient

THIOTEPA

Strength

200MG

Dosage form

POWDER

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 208264

Product number

003

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9931458	May 31, 2037	in 11 yr 1 mo	Product