Suppliers and packages for tradename: gadobutrol
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gadobutrol
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hainan Poly Pharm | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 217480 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-212-54 | 20 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-54) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32) | 2023-10-20 |
| Hainan Poly Pharm | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 217480 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-212-80 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-80) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32) | 2023-10-20 |
| Hainan Poly Pharm | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 217480 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-214-54 | 20 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-54) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34) | 2023-10-20 |
| Hainan Poly Pharm | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 217480 | ANDA | Slate Run Pharmaceuticals, LLC | 70436-214-80 | 1 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-80) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34) | 2023-10-20 |
| Hengrui Pharma | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 216081 | ANDA | Fresenius Kabi USA, LLC | 65219-287-30 | 10 BOTTLE in 1 CARTON (65219-287-30) / 30 mL in 1 BOTTLE (65219-287-10) | 2023-10-01 |
| Hengrui Pharma | GADOBUTROL | gadobutrol | SOLUTION;INTRAVENOUS | 216081 | ANDA | Fresenius Kabi USA, LLC | 65219-289-65 | 10 BOTTLE in 1 CARTON (65219-289-65) / 65 mL in 1 BOTTLE (65219-289-10) | 2023-10-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
