FDA.reportPublic FDA data

Application 214377

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VERQUVOVERICIGUATTABLET;ORAL2.5MGYesNo
002VERQUVOVERICIGUATTABLET;ORAL5MGYesNo
003VERQUVOVERICIGUATTABLET;ORAL10MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-5028VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5028VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5028VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5028VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5029VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5029VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5029VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5029VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5030VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5030VERQUVOvericiguatMerck Sharp & Dohme Corp.NDACurrent
0006-5030VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent
0006-5030VERQUVOvericiguatMerck Sharp & Dohme LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84822SUPPL 2026-01-22
84817SUPPL 2026-01-22
74227SUPPL 2023-05-11
74226SUPPL 2023-05-11
74220SUPPL 2023-05-11
72721SUPPL2022-11-27
72715SUPPL2022-11-25
66264ORIG2021-02-17
65949ORIG2021-01-21
65943ORIG2021-01-19