65219-080Level 3
Gadoterate Meglumine (gadoterate meglumine)
**Product type:** Human Prescription Drug
**Active ingredient:** GADOTERATE MEGLUMINE
**Strength:** 376.9 mg/mL
**Dosage form:** Injection
**Route:** Intravenous
**Labeler:** Fresenius Kabi USA, LLC
**Marketing category:** ANDA (ANDA215304)
**Pharmacologic class:** Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA]
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