Orange Book product · Generic (ANDA)
GADOBUTROL
GADOBUTROL
Generic (ANDA)ANDA 219146TE APRX ZENARA
At a glance
Jun 08, 2026
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 08, 2026
11 d ago
Today
Pharmaceutical detail
Active ingredient
GADOBUTROL
Strength
1.20944GM/2ML (604.72MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 219146
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GADOBUTROL
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.
