Orange Book product · Brand (NDA)
DYANAVEL XR 10
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
At a glance
Nov 04, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 04, 2021
4 yr 8 mo ago
Today
Patent 8337890 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 9675704 expires
Listed drug product patent expiration.
Mar 15, 2027
in 9 mo
Patent 11590081 expires
Listed drug product patent expiration.
Sep 24, 2038
in 12 yr 5 mo
Patent 12458592 expires
Listed method-of-use patent (U-3538) expiration.
Feb 11, 2040
in 13 yr 10 mo
Pharmaceutical detail
Active ingredient
AMPHETAMINE; AMPHETAMINE ASPARTATE/DEXTROAMPHETAMINE SULFATE
Strength
8MG;EQ 2MG BASE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 210526
Product number
002
Marketing status
RX
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 (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8337890 | Mar 15, 2027 | in 9 mo | Product |
| 8747902 | Mar 15, 2027 | in 9 mo | Product |
| 9675704 | Mar 15, 2027 | in 9 mo | Product |
| 11590081 | Sep 24, 2038 | in 12 yr 5 mo | ProductU-3538 |
| 12458592 | Feb 11, 2040 | in 13 yr 10 mo | U-3538 |
