Orange Book product · Brand (NDA)

ABILIFY

ARIPIPRAZOLE

Brand (NDA)NDA 021713DISCN OTSUKA

Dec 10, 2004

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 10, 2004
21 yr 10 mo ago
Today
Patent 8759350 expires
Listed method-of-use patent (U-1529) expiration.
Mar 02, 2027
in 9 mo

Active ingredient

ARIPIPRAZOLE

Strength

1MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION

Route

ORAL

TE code

Not listed

Application

NDA 021713

Product number

001

Marketing status

DISCN

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
8759350	Mar 02, 2027	in 9 mo	U-1529