| 70436-216-51 |
70436-216 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20250416 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
5 VIAL, MULTI-DOSE in 1 CARTON (70436-216-51) / 30 mL in 1 VIAL, MULTI-DOSE (70436-216-77) |
| 70436-212-54 |
70436-212 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20231020 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
20 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-54) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32) |
| 70436-212-80 |
70436-212 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20231020 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
1 VIAL, SINGLE-DOSE in 1 CARTON (70436-212-80) / 7.5 mL in 1 VIAL, SINGLE-DOSE (70436-212-32) |
| 70436-216-81 |
70436-216 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20250416 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
5 VIAL, MULTI-DOSE in 1 CARTON (70436-216-81) / 30 mL in 1 VIAL, MULTI-DOSE (70436-216-36) |
| 70436-213-82 |
70436-213 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20250416 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
10 VIAL, SINGLE-DOSE in 1 CARTON (70436-213-82) / 10 mL in 1 VIAL, SINGLE-DOSE (70436-213-33) |
| 70436-217-50 |
70436-217 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20250416 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
1 VIAL, MULTI-DOSE in 1 CARTON (70436-217-50) / 65 mL in 1 VIAL, MULTI-DOSE (70436-217-78) |
| 70436-217-80 |
70436-217 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20250416 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
1 VIAL, MULTI-DOSE in 1 CARTON (70436-217-80) / 65 mL in 1 VIAL, MULTI-DOSE (70436-217-38) |
| 70436-214-54 |
70436-214 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20231020 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
20 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-54) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34) |
| 70436-214-80 |
70436-214 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20231020 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
1 VIAL, SINGLE-DOSE in 1 CARTON (70436-214-80) / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34) |
| 70436-218-84 |
70436-218 |
HUMAN PRESCRIPTION DRUG |
gadobutrol |
gadobutrol |
INJECTION |
INTRAVENOUS |
20250416 |
N/A |
ANDA |
ANDA217480 |
Slate Run Pharmaceuticals, LLC |
GADOBUTROL |
604.72 mg/mL |
3 VIAL, SINGLE-DOSE in 1 CARTON (70436-218-84) / 2 mL in 1 VIAL, SINGLE-DOSE (70436-218-30) |