FDA.reportPublic FDA data

Application 209939

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PREVYMISLETERMOVIRTABLET;ORAL240MGYesNo
002PREVYMISLETERMOVIRTABLET;ORAL480MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3075PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3075PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3075PREVYMISLETERMOVIRMerck Sharp & Dohme LLCNDACurrent
0006-3075PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3075PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3075PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3075PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3075PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3076PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3076PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3076PREVYMISLETERMOVIRMerck Sharp & Dohme LLCNDACurrent
0006-3076PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3076PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3076PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3076PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent
0006-3076PREVYMISLETERMOVIRMerck Sharp & Dohme Corp.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81083SUPPL 2025-02-06
80989SUPPL 2025-02-05
79519SUPPL 2024-10-15
79518SUPPL 2024-10-15
79533SUPPL 2024-09-03
79532SUPPL 2024-09-03
74990SUPPL 2023-08-04
74977SUPPL 2023-08-03
74452SUPPL 2023-06-06
74435SUPPL 2023-06-06
50344ORIG2020-04-17
62302SUPPL2020-03-24
62279SUPPL2020-03-24
61446SUPPL2019-12-26
61417SUPPL2019-12-23
59895SUPPL2019-09-03
59883SUPPL2019-08-30
57924SUPPL2019-03-07
57919SUPPL2019-03-07
50755ORIG2017-12-18
50345ORIG2017-11-08