FDA.reportPublic FDA data

Application 216986

Type
NDA
Sponsor
GUERBET

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELUCIREMGADOPICLENOLSOLUTION;INTRAVENOUS1.4553GM/3ML (485.1MG/ML)YesYes
002ELUCIREMGADOPICLENOLSOLUTION;INTRAVENOUS3.63825GM/7.5ML (485.1MG/ML)YesYes
003ELUCIREMGADOPICLENOLSOLUTION;INTRAVENOUS4.851GM/10ML (485.1MG/ML)YesYes
004ELUCIREMGADOPICLENOLSOLUTION;INTRAVENOUS7.2765GM/15ML (485.1MG/ML)YesYes
005ELUCIREMGADOPICLENOLSOLUTION;INTRAVENOUS14.553GM/30ML (485.1MG/ML)YesYes
006ELUCIREMGADOPICLENOLSOLUTION;INTRAVENOUS24.255GM/50ML (485.1MG/ML)YesYes
007ELUCIREMGADOPICLENOLSOLUTION;INTRAVENOUS48.51GM/100ML (485.1MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0270-7015VuewayGadopiclenolBRACCO DIAGNOSTICS INCNDACurrent
0270-7015VuewayGadopiclenolBRACCO DIAGNOSTICS INCNDACurrent
0270-7020VuewayGadopiclenolBRACCO DIAGNOSTICS INCNDACurrent
0270-7025VuewayGadopiclenolBRACCO DIAGNOSTICS INCNDACurrent
0270-7030VuewayGadopiclenolBRACCO DIAGNOSTICS INCNDACurrent
0270-7035VuewayGadopiclenolBRACCO DIAGNOSTICS INCNDACurrent
67684-4230ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4230ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4230ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4231ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4231ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4231ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4232ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4232ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4232ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4233ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4240ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4241ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4242ELUCIREMgadopiclenolGuerbet LLCNDACurrent
67684-4250ELUCIREMgadopiclenolGuerbet LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85133SUPPL 2026-02-24
85112SUPPL 2026-02-24
85147SUPPL 2026-02-20
81486SUPPL 2025-03-07
81466SUPPL 2025-03-06
79414SUPPL 2024-08-16
79198SUPPL 2024-07-24
79184SUPPL 2024-07-24
77351SUPPL 2024-01-29
77330SUPPL 2024-01-29
72429ORIG2022-10-20
72139ORIG2022-09-22
72127ORIG2022-09-21
72126ORIG2022-09-21