Orange Book product · Brand (NDA)
CARBAGLU
CARGLUMIC ACID
At a glance
Mar 18, 2010
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 18, 2010
16 yr 6 mo ago
Today
Exclusivity ends · ODE-345
Orphan-drug exclusivity (7 years)
Jan 22, 2028
in 1 yr 7 mo
Pharmaceutical detail
Active ingredient
CARGLUMIC ACID
Strength
200MG
Dosage form
TABLET, FOR SUSPENSION
Route
ORAL
TE code
AB
Application
NDA 022562
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-345Orphan-drug exclusivity (7 years)
Jan 22, 2028
in 1 yr 7 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.
