| 67684-4251-1 |
67684-4251 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20251114 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-1) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4251-2 |
67684-4251 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20251114 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-2) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4251-3 |
67684-4251 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20251114 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4251-4 |
67684-4251 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20251114 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4251-5 |
67684-4251 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20251114 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4251-6 |
67684-4251 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20251114 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4251-7 |
67684-4251 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20251114 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4251-7) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 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 |
| 0270-7020-38 |
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 |
| 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 |
| 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 |