Orange Book product · Brand (NDA)

DOCIVYX

DOCETAXEL

Brand (NDA)NDA 215813RX AVYXA HOLDINGS

Nov 22, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 22, 2022
3 yr 8 mo ago
Today
Patent 10398785 expires
Listed drug product patent expiration.
Mar 14, 2036
in 9 yr 11 mo

Active ingredient

DOCETAXEL

Strength

20MG/2ML (10MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 215813

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
10398785	Mar 14, 2036	in 9 yr 11 mo	Product