Orange Book product · Brand (NDA)

OPIPZA

ARIPIPRAZOLE

Brand (NDA)NDA 216655RX XIAMEN LP PHARM CO

Jul 22, 2024

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 22, 2024
1 yr 11 mo ago
Today
Patent 11331315 expires
Listed drug product patent expiration.
Nov 03, 2040
in 14 yr 7 mo
Patent 11701352 expires
Listed drug product patent expiration.
Dec 15, 2041
in 15 yr 9 mo

Active ingredient

ARIPIPRAZOLE

Strength

5MG

Dosage form

FILM

Route

ORAL

TE code

Not listed

Application

NDA 216655

Product number

002

Marketing status

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
11331315	Nov 03, 2040	in 14 yr 7 mo	Product
11701352	Dec 15, 2041	in 15 yr 9 mo	Product