← FDA Drug Approvals (Drugs@FDA)
GADOTERATE MEGLUMINE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: VIWIT PHARM · Approved 2026-08-10
Drug application
- FDA Application #
ANDA219286
- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- GADOTERATE MEGLUMINE
- Generic name
- Gadoterate Meglumine
- Active ingredients
- GADOTERATE MEGLUMINE
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Marketing status
- Prescription
- Sponsor
- VIWIT PHARM
- First approval
- 2026-08-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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