Orange Book product · Brand (NDA)
DIACOMIT
STIRIPENTOL
At a glance
Aug 20, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 20, 2018
7 yr 11 mo ago
Today
Exclusivity ends · ODE-403
Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
Pharmaceutical detail
Active ingredient
STIRIPENTOL
Strength
500MG/PACKET
Dosage form
FOR SUSPENSION
Route
ORAL
TE code
Not listed
Application
NDA 207223
Product number
002
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-403Orphan-drug exclusivity (7 years)
Jul 14, 2029
in 3 yr 1 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
