65219-281-02 |
65219-281 |
HUMAN PRESCRIPTION DRUG |
Gadobutrol |
Gadobutrol |
INJECTION |
INTRAVENOUS |
20230414 |
N/A |
ANDA |
ANDA215061 |
Fresenius Kabi USA, LLC |
GADOBUTROL |
604.72 mg/mL |
5 CARTON in 1 BOX (65219-281-02) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE (65219-281-00) |
65219-281-07 |
65219-281 |
HUMAN PRESCRIPTION DRUG |
Gadobutrol |
Gadobutrol |
INJECTION |
INTRAVENOUS |
20230414 |
N/A |
ANDA |
ANDA215061 |
Fresenius Kabi USA, LLC |
GADOBUTROL |
604.72 mg/mL |
2 CARTON in 1 BOX (65219-281-07) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSE (65219-281-03) |
65219-281-10 |
65219-281 |
HUMAN PRESCRIPTION DRUG |
Gadobutrol |
Gadobutrol |
INJECTION |
INTRAVENOUS |
20230414 |
N/A |
ANDA |
ANDA215061 |
Fresenius Kabi USA, LLC |
GADOBUTROL |
604.72 mg/mL |
2 CARTON in 1 BOX (65219-281-10) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE (65219-281-08) |
65219-281-15 |
65219-281 |
HUMAN PRESCRIPTION DRUG |
Gadobutrol |
Gadobutrol |
INJECTION |
INTRAVENOUS |
20230414 |
N/A |
ANDA |
ANDA215061 |
Fresenius Kabi USA, LLC |
GADOBUTROL |
604.72 mg/mL |
2 CARTON in 1 BOX (65219-281-15) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (65219-281-05) |