Orange Book product · Brand (NDA)
NOURIANZ
ISTRADEFYLLINE
Brand (NDA)NDA 022075RX KYOWA KIRIN
At a glance
Aug 27, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 27, 2019
6 yr 11 mo ago
Today
Patent 8318201 expires
Listed drug product patent expiration.
Sep 05, 2027
in 1 yr 3 mo
Patent 7727993 expires
Listed drug product patent expiration.
Jan 28, 2028
in 1 yr 8 mo
Pharmaceutical detail
Active ingredient
ISTRADEFYLLINE
Strength
20MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 022075
Product number
001
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 (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8318201 | Sep 05, 2027 | in 1 yr 3 mo | Product |
| 7727993 | Jan 28, 2028 | in 1 yr 8 mo | ProductU-2623 |
