Orange Book product · Brand (NDA)
OMNISCAN
GADODIAMIDE
Brand (NDA)NDA 020123RX GE HEALTHCARE
At a glance
Jan 08, 1993
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 08, 1993
33 yr 11 mo ago
Today
Pharmaceutical detail
Active ingredient
GADODIAMIDE
Strength
287MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 020123
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.
