Orange Book product · Brand (NDA)

EVDI

TRABECTEDIN

Brand (NDA)NDA 220837RX APOTEX

May 01, 2026

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
May 01, 2026
2 mo ago
Today
Patent 12303506 expires
Listed drug product patent expiration.
Feb 18, 2043
in 16 yr 11 mo

Active ingredient

TRABECTEDIN

Strength

1MG/20ML (0.05MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 220837

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
12303506	Feb 18, 2043	in 16 yr 11 mo	Product