FDA.report

Application 210806

Type
NDA
Sponsor
MSD MERCK CO

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001PIFELTRODORAVIRINETABLET;ORAL100MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-3069PIFELTROdoravirineMerck Sharp & Dohme Corp.NDACurrent
0006-3069PIFELTROdoravirineMerck Sharp & Dohme Corp.NDACurrent
0006-3069PIFELTROdoravirineMerck Sharp & Dohme LLCNDACurrent
0006-3069PIFELTROdoravirineMerck Sharp & Dohme LLCNDACurrent
0006-3069PIFELTROdoravirineMerck Sharp & Dohme Corp.NDACurrent
0006-3069PIFELTROdoravirineMerck Sharp & Dohme Corp.NDACurrent
0006-3069PIFELTROdoravirineMerck Sharp & Dohme Corp.NDACurrent
0006-3069PIFELTROdoravirineMerck Sharp & Dohme Corp.NDACurrent
50090-6237PIFELTROdoravirineA-S Medication SolutionsNDACurrent
50090-6268PIFELTROdoravirineA-S Medication SolutionsNDACurrent

Documents

DocumentSubmission typeDate
84028SUPPL 2025-10-31
80186SUPPL 2024-11-08
80182SUPPL 2024-11-08
70022SUPPL2022-02-01
70006SUPPL2022-01-31
60540SUPPL2019-10-11
60535SUPPL2019-10-11
60076SUPPL2019-09-20
60072SUPPL2019-09-20
55852ORIG2018-10-09
55373ORIG2018-08-30
55372ORIG2018-08-30