Orange Book product · Brand (NDA)

CYCLOPHOSPHAMIDE

Brand (NDA)NDA 210735RX EUGIA PHARMA SPECLTS

Aug 25, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 25, 2021
4 yr 11 mo ago
Today
Patent 9662342 expires
Listed drug product patent expiration.
Jun 26, 2035
in 9 yr 2 mo

Active ingredient

CYCLOPHOSPHAMIDE

Strength

1GM/5ML (200MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 210735

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
9662342	Jun 26, 2035	in 9 yr 2 mo	Product