Details for New Drug Application (NDA): 216081
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NDA 216081 describes GADOBUTROL, which is a drug marketed by Hainan Poly Pharm and Hengrui Pharma and is included in three NDAs. It is available from two suppliers. Additional details are available on the GADOBUTROL profile page.
The generic ingredient in GADOBUTROL is gadobutrol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.
The generic ingredient in GADOBUTROL is gadobutrol. There is one drug master file entry for this compound. Three suppliers are listed for this compound. Additional details are available on the gadobutrol profile page.
Summary for 216081
| Tradename: | GADOBUTROL |
| Applicant: | Hengrui Pharma |
| Ingredient: | gadobutrol |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 216081
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 216081
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 216081 | ANDA | Fresenius Kabi USA, LLC | 65219-287 | 65219-287-30 | 10 BOTTLE in 1 CARTON (65219-287-30) / 30 mL in 1 BOTTLE (65219-287-10) |
| GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 216081 | ANDA | Fresenius Kabi USA, LLC | 65219-289 | 65219-289-65 | 10 BOTTLE in 1 CARTON (65219-289-65) / 65 mL in 1 BOTTLE (65219-289-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 18.1416GM/30ML (604.72MG/ML) | ||||
| Approval Date: | Sep 8, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 29, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 39.3068GM/65ML (604.72MG/ML) | ||||
| Approval Date: | Sep 8, 2023 | TE: | AP | RLD: | No | ||||
| Regulatory Exclusivity Expiration: | Apr 29, 2024 | ||||||||
| Regulatory Exclusivity Use: | COMPETITIVE GENERIC THERAPY | ||||||||
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