FDA.report

Application 210455

Type
NDA
Sponsor
JANSSEN PRODS

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001SYMTUZACOBICISTAT; DARUNAVIR; EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATETABLET;ORAL150MG;800MG;200MG;EQ 10MG BASEYesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent
59676-800SymtuzaDarunavir, Cobicistat, Emtricitabine, and Tenofovir alafenamideJanssen Products LPNDACurrent

Documents

DocumentSubmission typeDate
73935SUPPL 2023-04-03
73924SUPPL 2023-04-03
72473SUPPL2022-10-26
72448SUPPL2022-10-24
70778SUPPL2022-04-18
70771SUPPL2022-04-15
68247SUPPL2021-08-02
68231SUPPL2021-07-30
69279SUPPL2021-06-29
67976SUPPL2021-06-29
65753SUPPL2020-12-28
65723SUPPL2020-12-23
62022SUPPL2020-03-04
62019SUPPL2020-03-04
58936SUPPL2019-06-04
58905SUPPL2019-05-31
57836SUPPL2019-02-28
57824SUPPL2019-02-27
57546SUPPL2019-02-13
57356SUPPL2019-01-28
56704ORIG2018-12-11
54955ORIG2018-07-24
54912ORIG2018-07-18
67067SUPPL1900-01-01
67066SUPPL1900-01-01
62936ORIG1900-01-01
62929SUPPL1900-01-01
62925SUPPL1900-01-01