Orange Book product · Brand (NDA)
SEZABY
PHENOBARBITAL SODIUM
At a glance
Nov 17, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
2
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 17, 2022
3 yr 8 mo ago
Today
Exclusivity ends · ODE-414
Orphan-drug exclusivity (7 years)
Nov 17, 2029
in 3 yr 6 mo
Patent 11857683 expires
Listed drug product patent expiration.
Apr 07, 2042
in 16 yr
Patent 12636254 expires
Listed drug product patent expiration.
Apr 07, 2042
in 16 yr
Pharmaceutical detail
Active ingredient
PHENOBARBITAL SODIUM
Strength
100MG/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 215910
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.
Marketing exclusivity (1)
- ODE-414Orphan-drug exclusivity (7 years)
Nov 17, 2029
in 3 yr 6 mo
Listed patents (2)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11857683 | Apr 07, 2042 | in 16 yr | ProductU-3779 |
| 12636254 | Apr 07, 2042 | in 16 yr | ProductU-3779 |
