Application 206353

Type
NDA
Sponsor
BRISTOL-MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EVOTAZATAZANAVIR SULFATE; COBICISTATTABLET;ORALEQ 300MG BASE;150MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-3641EVOTAZatazanavir and cobicistatE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3641EVOTAZatazanavir and cobicistatE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3641EVOTAZatazanavir and cobicistatE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3641EVOTAZatazanavir and cobicistatE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3641EVOTAZatazanavir and cobicistatE.R. Squibb & Sons, L.L.C.NDACurrent
50090-1724EVOTAZatazanavir and cobicistatA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82181SUPPL 2025-05-14
82246SUPPL 2025-05-12
74248SUPPL 2023-05-15
74243SUPPL 2023-05-15
64187SUPPL2020-08-03
64173SUPPL2020-08-03
62651SUPPL2020-04-23
62644SUPPL2020-04-23
53770SUPPL2018-04-23
53739SUPPL2018-04-19
47022SUPPL2017-01-30
47018SUPPL2017-01-30
40543SUPPL2016-07-05
10567SUPPL2016-07-05
24515ORIG2016-04-15
23020ORIG2016-04-15
40542SUPPL2015-07-24
10566SUPPL2015-07-24
10565ORIG2015-02-02
19719ORIG2015-01-30