Orange Book product · Brand (NDA)
ADZENYS ER
AMPHETAMINE
At a glance
Sep 15, 2017
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 15, 2017
8 yr 11 mo ago
Today
Patent 8709491 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 9017731 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Patent 9265737 expires
Listed drug product patent expiration.
Jun 28, 2032
in 6 yr 1 mo
Pharmaceutical detail
Active ingredient
AMPHETAMINE
Strength
EQ 1.25MG BASE/ML
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 204325
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8709491 | Jun 28, 2032 | in 6 yr 1 mo | Product |
| 9017731 | Jun 28, 2032 | in 6 yr 1 mo | Product |
| 9265737 | Jun 28, 2032 | in 6 yr 1 mo | Product |
