Orange Book product · Brand (NDA)

CYCLOPHOSPHAMIDE

Brand (NDA)NDA 212501TE APRX DR REDDYS

Jul 30, 2020

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 30, 2020
6 yr ago
Today
Patent 10993952 expires
Listed drug product patent expiration.
Feb 15, 2036
in 9 yr 10 mo
Patent 12329767 expires
Listed drug product patent expiration.
Feb 15, 2036
in 9 yr 10 mo

Active ingredient

CYCLOPHOSPHAMIDE

Strength

1GM/5ML (200MG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Application

NDA 212501

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
10993952	Feb 15, 2036	in 9 yr 10 mo	Product
12329767	Feb 15, 2036	in 9 yr 10 mo	Product