FDA.reportPublic FDA data

Application 022225

Type
NDA
Sponsor
ORGANON SUB MERCK

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BRIDIONSUGAMMADEX SODIUMSOLUTION;INTRAVENOUSEQ 500MG BASE/5ML (EQ 100MG BASE/ML)YesYes
002BRIDIONSUGAMMADEX SODIUMSOLUTION;INTRAVENOUSEQ 200MG BASE/2ML (EQ 100MG BASE/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-5423BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
0006-5423BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
0006-5423BRIDIONsugammadexMerck Sharp & Dohme LLCNDACurrent
0006-5423BRIDIONsugammadexMerck Sharp & Dohme LLCNDACurrent
0006-5423BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
0006-5423BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
0006-5423BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
0006-5425BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
0006-5425BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
0006-5425BRIDIONsugammadexMerck Sharp & Dohme LLCNDACurrent
0006-5425BRIDIONsugammadexMerck Sharp & Dohme LLCNDACurrent
0006-5425BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
0006-5425BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
0006-5425BRIDIONsugammadexMerck Sharp & Dohme Corp.NDACurrent
71872-7187BRIDIONsugammadexMedical Purchasing Solutions, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80584SUPPL 2024-12-16
80565SUPPL 2024-12-13
72649SUPPL2022-11-18
72658SUPPL2022-11-17
68010SUPPL2021-07-02
67941SUPPL2021-06-29
66005SUPPL2021-01-27
66004SUPPL2021-01-27
65986SUPPL2021-01-26
65985SUPPL2021-01-26
63514SUPPL2020-06-12
63473SUPPL2020-06-10
61088SUPPL2019-11-29
45652SUPPL2016-10-26
24263ORIG2016-02-04
21964ORIG2016-02-04
29429ORIG2015-12-16
17105ORIG2015-12-16