Orange Book product · Generic (ANDA)
CLARISCAN
GADOTERATE MEGLUMINE
Generic (ANDA)ANDA 210016TE APRX GE HEALTHCARE
At a glance
Nov 24, 2020
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Nov 24, 2020
5 yr 8 mo ago
Today
Pharmaceutical detail
Active ingredient
GADOTERATE MEGLUMINE
Strength
1.8845GM/5ML (376.9MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
ANDA 210016
Product number
005
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of GADOTERATE MEGLUMINE
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.
