FDA.reportPublic FDA data

Application 203100

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001STRIBILDCOBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATETABLET;ORAL150MG;150MG;200MG;300MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50090-1318Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateA-S Medication SolutionsNDACurrent
50090-1318Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateA-S Medication SolutionsNDACurrent
53808-0887Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateState of Florida DOH Central PharmacyNDACurrent
61958-1201Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, Inc.NDACurrent
61958-1201Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, Inc.NDACurrent
61958-1201Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, Inc.NDACurrent
61958-1201Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, Inc.NDACurrent
61958-1201Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateGilead Sciences, Inc.NDACurrent
69189-1201Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateAvera McKennan HospitalNDACurrent
70518-0674Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent
70518-0674Stribildelvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68583SUPPL2021-09-13
68570SUPPL2021-09-10
64481SUPPL2020-09-02
64397SUPPL2020-08-24
57593SUPPL2019-02-14
57490SUPPL2019-02-07
56425SUPPL2018-11-13
56281SUPPL2018-11-06
55154SUPPL2018-08-10
55143SUPPL2018-08-09
49645SUPPL2017-08-31
49642SUPPL2017-08-31
48288SUPPL2017-05-09
48248SUPPL2017-05-05
47985SUPPL2017-04-12
47908SUPPL2017-04-10
47042SUPPL2017-01-31
47033SUPPL2017-01-27
45284SUPPL2016-09-19
45305SUPPL2016-09-15
32376SUPPL2016-02-23
19425SUPPL2016-02-23
40263SUPPL2015-07-30
32375SUPPL2015-07-30
19424SUPPL2014-12-19
10161SUPPL2014-12-18
40262SUPPL2014-09-03
32374SUPPL2014-09-02
40261SUPPL2013-10-25
32373SUPPL2013-10-25
19423SUPPL2013-10-08
10160SUPPL2013-10-08
44875ORIG2012-10-10
22910ORIG2012-10-10
32372ORIG2012-08-29
19422ORIG2012-08-28
52457ORIG1900-01-01
52456ORIG1900-01-01