Orange Book product · Brand (NDA)

FRINDOVYX

CYCLOPHOSPHAMIDE

Brand (NDA)NDA 210852RX AVYXA HOLDINGS

Jun 07, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 07, 2023
3 yr 1 mo ago
Today
Patent 10849916 expires
Listed drug product patent expiration.
Jul 13, 2035
in 9 yr 2 mo
Patent 11382923 expires
Listed drug product patent expiration.
Dec 01, 2035
in 9 yr 7 mo

Active ingredient

CYCLOPHOSPHAMIDE

Strength

1GM/2ML (500MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 210852

Product number

002

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
10849916	Jul 13, 2035	in 9 yr 2 mo	Product
11382923	Dec 01, 2035	in 9 yr 7 mo	Product