Application 203094

Type
NDA
Sponsor
GILEAD SCIENCES INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TYBOSTCOBICISTATTABLET;ORAL150MGYesYes
002TYBOSTCOBICISTATTABLET;ORAL90MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
61958-1401TybostCOBICISTATGilead Sciences, Inc.NDACurrent
61958-1401TybostCOBICISTATGilead Sciences, Inc.NDACurrent
61958-1401TybostCOBICISTATGilead Sciences, Inc.NDACurrent
61958-1401TybostCOBICISTATGilead Sciences, Inc.NDACurrent
61958-1401TybostCOBICISTATGilead Sciences, Inc.NDACurrent
61958-1401TybostCOBICISTATGilead Sciences, Inc.NDACurrent
61958-1401TybostCOBICISTATGilead Sciences, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82636SUPPL 2026-05-04
82635SUPPL 2026-05-04
82641SUPPL 2025-06-24
82640SUPPL 2025-06-24
68586SUPPL2021-09-13
68568SUPPL2021-09-10
64480SUPPL2020-09-02
64396SUPPL2020-08-24
60245SUPPL2019-10-07
60219SUPPL2019-10-04
59828SUPPL2019-08-26
59825SUPPL2019-08-23
56216SUPPL2018-10-31
56210SUPPL2018-10-31
55150SUPPL2018-08-10
55057SUPPL2018-07-30
49632SUPPL2017-08-30
49586SUPPL2017-08-30
48295SUPPL2017-05-09
48247SUPPL2017-05-05
40259SUPPL2016-06-21
10157SUPPL2016-06-21
40258SUPPL2015-12-01
32370SUPPL2015-11-27
24426ORIG2015-05-28
22908ORIG2015-05-28
19419ORIG2014-10-03
10156ORIG2014-09-29
32369ORIG2014-09-26
62920SUPPL1900-01-01
62919SUPPL1900-01-01