Orange Book product · Brand (NDA)
PROHANCE MULTIPACK
GADOTERIDOL
Brand (NDA)NDA 021489RX BRACCO
At a glance
Oct 09, 2003
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 09, 2003
23 yr ago
Today
Pharmaceutical detail
Active ingredient
GADOTERIDOL
Strength
279.3MG/ML
Dosage form
INJECTABLE
Route
INJECTION
TE code
Not listed
Application
NDA 021489
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.
