Orange Book product · Brand (NDA)
DATSCAN
IOFLUPANE I-123
Brand (NDA)NDA 022454TE APRX GE HLTHCARE INC
At a glance
Jan 14, 2011
Approved
Brand (NDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 14, 2011
15 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
IOFLUPANE I-123
Strength
5mCi/2.5ML (2mCi/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 022454
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.
