0270-7015-46 |
0270-7015 |
HUMAN PRESCRIPTION DRUG |
Vueway |
Gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
BRACCO DIAGNOSTICS INC |
GADOPICLENOL |
485.1 mg/mL |
25 VIAL, SINGLE-DOSE in 1 CASE (0270-7015-46) / 30 mL in 1 VIAL, SINGLE-DOSE |
0270-7015-48 |
0270-7015 |
HUMAN PRESCRIPTION DRUG |
Vueway |
Gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
BRACCO DIAGNOSTICS INC |
GADOPICLENOL |
485.1 mg/mL |
25 VIAL, SINGLE-DOSE in 1 CASE (0270-7015-48) / 50 mL in 1 VIAL, SINGLE-DOSE |
0270-7015-64 |
0270-7015 |
HUMAN PRESCRIPTION DRUG |
Vueway |
Gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
BRACCO DIAGNOSTICS INC |
GADOPICLENOL |
485.1 mg/mL |
6 CARTON in 1 CASE (0270-7015-64) / 1 VIAL, SINGLE-DOSE in 1 CARTON / 100 mL in 1 VIAL, SINGLE-DOSE |
0270-7020-38 |
0270-7020 |
HUMAN PRESCRIPTION DRUG |
Vueway |
Gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
BRACCO DIAGNOSTICS INC |
GADOPICLENOL |
485.1 mg/mL |
10 VIAL, SINGLE-DOSE in 1 CASE (0270-7020-38) / 3 mL in 1 VIAL, SINGLE-DOSE |
0270-7025-40 |
0270-7025 |
HUMAN PRESCRIPTION DRUG |
Vueway |
Gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
BRACCO DIAGNOSTICS INC |
GADOPICLENOL |
485.1 mg/mL |
10 VIAL, SINGLE-DOSE in 1 CASE (0270-7025-40) / 7.5 mL in 1 VIAL, SINGLE-DOSE |
0270-7030-42 |
0270-7030 |
HUMAN PRESCRIPTION DRUG |
Vueway |
Gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
BRACCO DIAGNOSTICS INC |
GADOPICLENOL |
485.1 mg/mL |
10 VIAL, SINGLE-DOSE in 1 CASE (0270-7030-42) / 10 mL in 1 VIAL, SINGLE-DOSE |
0270-7035-44 |
0270-7035 |
HUMAN PRESCRIPTION DRUG |
Vueway |
Gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
BRACCO DIAGNOSTICS INC |
GADOPICLENOL |
485.1 mg/mL |
10 VIAL, SINGLE-DOSE in 1 CASE (0270-7035-44) / 15 mL in 1 VIAL, SINGLE-DOSE |
67684-4230-1 |
67684-4230 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 VIAL in 1 CARTON (67684-4230-1) / 3 mL in 1 VIAL |
67684-4230-2 |
67684-4230 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
10 VIAL in 1 CARTON (67684-4230-2) / 3 mL in 1 VIAL |
67684-4231-1 |
67684-4231 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 VIAL in 1 CARTON (67684-4231-1) / 7.5 mL in 1 VIAL |
67684-4231-2 |
67684-4231 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
10 VIAL in 1 CARTON (67684-4231-2) / 7.5 mL in 1 VIAL |
67684-4232-1 |
67684-4232 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 VIAL in 1 CARTON (67684-4232-1) / 10 mL in 1 VIAL |
67684-4232-2 |
67684-4232 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
10 VIAL in 1 CARTON (67684-4232-2) / 10 mL in 1 VIAL |
67684-4233-1 |
67684-4233 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 VIAL in 1 CARTON (67684-4233-1) / 15 mL in 1 VIAL |
67684-4233-2 |
67684-4233 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
10 VIAL in 1 CARTON (67684-4233-2) / 15 mL in 1 VIAL |
67684-4240-1 |
67684-4240 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 SYRINGE in 1 CARTON (67684-4240-1) / 7.5 mL in 1 SYRINGE |
67684-4240-2 |
67684-4240 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
10 SYRINGE in 1 CARTON (67684-4240-2) / 7.5 mL in 1 SYRINGE |
67684-4241-1 |
67684-4241 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 SYRINGE in 1 CARTON (67684-4241-1) / 10 mL in 1 SYRINGE |
67684-4241-2 |
67684-4241 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
10 SYRINGE in 1 CARTON (67684-4241-2) / 10 mL in 1 SYRINGE |
67684-4242-1 |
67684-4242 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 SYRINGE in 1 CARTON (67684-4242-1) / 15 mL in 1 SYRINGE |