# DOTAREM
> **NDA204781** · New Drug Application · Sponsor: GUERBET · Approved 2013-03-20
## Drug
- **FDA Application Number:** NDA204781
- **Application type:** New Drug Application
- **Brand name:** DOTAREM
- **Generic name:** GADOTERATE MEGLUMINE
- **Active ingredients:** GADOTERATE MEGLUMINE
- **Dosage form:** SOLUTION
- **Route:** INTRAVENOUS
- **Marketing status:** Prescription
- **Sponsor:** GUERBET
- **Manufacturer:** Guerbet LLC
- **First approval:** 2013-03-20
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204781)
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