Details for New Drug Application (NDA): 218749
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NDA 218749 describes GADOTERIDOL, which is a drug marketed by Hainan Poly and is included in one NDA. It is available from one supplier. Additional details are available on the GADOTERIDOL profile page.
The generic ingredient in GADOTERIDOL is gadoteridol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the gadoteridol profile page.
The generic ingredient in GADOTERIDOL is gadoteridol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the gadoteridol profile page.
Summary for 218749
| Tradename: | GADOTERIDOL |
| Applicant: | Hainan Poly |
| Ingredient: | gadoteridol |
| Patents: | 0 |
Pharmacology for NDA: 218749
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 218749
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GADOTERIDOL | gadoteridol | INJECTABLE;INJECTION | 218749 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-121 | 70436-121-31 | 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-31) / 5 mL in 1 VIAL, SINGLE-DOSE |
| GADOTERIDOL | gadoteridol | INJECTABLE;INJECTION | 218749 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-121 | 70436-121-33 | 5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-33) / 10 mL in 1 VIAL, SINGLE-DOSE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 279.3MG/ML | ||||
| Approval Date: | Feb 11, 2025 | TE: | AP | RLD: | No | ||||
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