| 67684-4250-3 |
67684-4250 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-3) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4250-4 |
67684-4250 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
25 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-4) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4250-5 |
67684-4250 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-5) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4250-6 |
67684-4250 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-6) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 67684-4250-7 |
67684-4250 |
HUMAN PRESCRIPTION DRUG |
ELUCIREM |
gadopiclenol |
INJECTION |
INTRAVENOUS |
20220921 |
N/A |
NDA |
NDA216986 |
Guerbet LLC |
GADOPICLENOL |
485.1 mg/mL |
12 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (67684-4250-7) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| 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 |
| 0270-7015-64 |
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 |
| 0270-7015-48 |
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 |
| 0270-7015-46 |
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 |