Orange Book product · Brand (NDA)
DYANAVEL XR
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
At a glance
Oct 19, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 19, 2015
10 yr 10 mo ago
Today
Patent 10086087 expires
Listed drug product patent expiration.
Mar 15, 2027
in 9 mo
Patent 8597684 expires
Listed drug product patent expiration.
Mar 15, 2027
in 9 mo
Patent 8747902 expires
Listed drug product patent expiration.
Mar 15, 2027
in 9 mo
Patent 8883217 expires
Listed drug product patent expiration.
Mar 15, 2027
in 9 mo
Patent 9675703 expires
Listed drug product patent expiration.
Mar 15, 2027
in 9 mo
Patent 8062667 expires
Listed drug product patent expiration.
Mar 29, 2029
in 2 yr 10 mo
Patent 11590228 expires
Listed drug product patent expiration.
Sep 07, 2036
in 10 yr 4 mo
Pharmaceutical detail
Active ingredient
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Strength
2MG/ML;EQ 0.5MG BASE/ML
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 208147
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10086087 | Mar 15, 2027 | in 9 mo | Product |
| 8597684 | Mar 15, 2027 | in 9 mo | Product |
| 8747902 | Mar 15, 2027 | in 9 mo | Product |
| 8883217 | Mar 15, 2027 | in 9 mo | Product |
| 9675703 | Mar 15, 2027 | in 9 mo | Product |
| 8062667 | Mar 29, 2029 | in 2 yr 10 mo | Product |
| 11590228 | Sep 07, 2036 | in 10 yr 4 mo | ProductU-3538 |
