Details for New Drug Application (NDA): 219286
✉ Email this page to a colleague
NDA 219286 describes GADOTERATE MEGLUMINE, which is a drug marketed by Hainan Poly, Hengrui Pharma, and Viwit Pharm, and is included in three NDAs. It is available from two suppliers. Additional details are available on the GADOTERATE MEGLUMINE profile page.
The generic ingredient in GADOTERATE MEGLUMINE is gadoterate meglumine. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.
The generic ingredient in GADOTERATE MEGLUMINE is gadoterate meglumine. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the gadoterate meglumine profile page.
Summary for 219286
| Tradename: | GADOTERATE MEGLUMINE |
| Applicant: | Viwit Pharm |
| Ingredient: | gadoterate meglumine |
| Patents: | 0 |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 3.769GM/10ML (376.9MG/ML) | ||||
| Approval Date: | Aug 10, 2026 | TE: | AP | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 5.6535GM/15ML (376.9MG/ML) | ||||
| Approval Date: | Aug 10, 2026 | TE: | AP | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 7.538GM/20ML (376.9MG/ML) | ||||
| Approval Date: | Aug 10, 2026 | TE: | AP | RLD: | No | ||||
Complete Access Available with Subscription
