Orange Book product · Generic (ANDA)
GADOTERATE MEGLUMINE
GADOTERATE MEGLUMINE
Generic (ANDA)ANDA 218073TE APRX HAINAN POLY
At a glance
Jun 17, 2024
Approved
Generic (ANDA)
Application
AP
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 17, 2024
2 yr 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 218073
Product number
001
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.
