FDA.report

Application 210807

Type
NDA
Sponsor
MSD MERCK CO

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001DELSTRIGODORAVIRINE; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL100MG;300MG;300MGYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-5007DELSTRIGOdoravirine, lamivudine, and tenofovir disoproxil fumarateMerck Sharp & Dohme Corp.NDACurrent
0006-5007DELSTRIGOdoravirine, lamivudine, and tenofovir disoproxil fumarateMerck Sharp & Dohme Corp.NDACurrent
0006-5007DELSTRIGOdoravirine, lamivudine, and tenofovir disoproxil fumarateMerck Sharp & Dohme LLCNDACurrent
0006-5007DELSTRIGOdoravirine, lamivudine, and tenofovir disoproxil fumarateMerck Sharp & Dohme LLCNDACurrent
0006-5007DELSTRIGOdoravirine, lamivudine, and tenofovir disoproxil fumarateMerck Sharp & Dohme Corp.NDACurrent
0006-5007DELSTRIGOdoravirine, lamivudine, and tenofovir disoproxil fumarateMerck Sharp & Dohme Corp.NDACurrent
0006-5007DELSTRIGOdoravirine, lamivudine, and tenofovir disoproxil fumarateMerck Sharp & Dohme Corp.NDACurrent
0006-5007DELSTRIGOdoravirine, lamivudine, and tenofovir disoproxil fumarateMerck Sharp & Dohme Corp.NDACurrent

Documents

DocumentSubmission typeDate
84027SUPPL 2025-10-31
83998SUPPL 2025-10-31
82569SUPPL 2025-06-13
82560SUPPL 2025-06-13
80187SUPPL 2024-11-08
80183SUPPL 2024-11-08
70023SUPPL2022-02-01
70007SUPPL2022-01-31
60539SUPPL2019-10-11
60536SUPPL2019-10-11
60075SUPPL2019-09-20
60071SUPPL2019-09-20
55853ORIG2018-10-09
55375ORIG2018-08-30
55374ORIG2018-08-30