Orange Book product · Brand (NDA)

TEPYLUTE

THIOTEPA

Brand (NDA)NDA 216984RX SHORLA

Jun 25, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 25, 2024
2 yr ago
Today
Patent 11975013 expires
Listed drug product patent expiration.
Aug 16, 2041
in 15 yr 5 mo
Patent 12622921 expires
Listed method-of-use patent (U-4530) expiration.
Aug 16, 2041
in 15 yr 5 mo

Active ingredient

THIOTEPA

Strength

15MG/1.5ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 216984

Product number

001

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
11975013	Aug 16, 2041	in 15 yr 5 mo	Product
12622921	Aug 16, 2041	in 15 yr 5 mo	U-4530