Orange Book product · Brand (NDA)
XURIDEN
URIDINE TRIACETATE
Brand (NDA)NDA 208169RX BTG INTL
At a glance
Sep 04, 2015
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 04, 2015
10 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
URIDINE TRIACETATE
Strength
2GM/PACKET
Dosage form
GRANULE
Route
ORAL
TE code
Not listed
Application
NDA 208169
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.
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.
