Orange Book product · Brand (NDA)

KYXATA

CARBOPLATIN

Brand (NDA)NDA 219921DISCN AVYXA HOLDINGS

Aug 08, 2025

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 08, 2025
11 mo ago
Today
Patent 12427104 expires
Listed drug product patent expiration.
Apr 01, 2045
in 19 yr 1 mo

Active ingredient

CARBOPLATIN

Strength

20MG/2ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 219921

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

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
12427104	Apr 01, 2045	in 19 yr 1 mo	Product