Orange Book product · Brand (NDA)

EVEKEO ODT

AMPHETAMINE SULFATE

Brand (NDA)NDA 209905DISCN AZURITY

Apr 16, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 16, 2021
5 yr 3 mo ago
Today
Patent 10441554 expires
Listed drug product patent expiration.
Mar 10, 2037
in 10 yr 11 mo
Patent 11160772 expires
Listed drug product patent expiration.
Mar 10, 2037
in 10 yr 11 mo

Active ingredient

AMPHETAMINE SULFATE

Strength

2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

TE code

Not listed

Application

NDA 209905

Product number

005

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
10441554	Mar 10, 2037	in 10 yr 11 mo	Product
11160772	Mar 10, 2037	in 10 yr 11 mo	Product