FDA.reportPublic FDA data

Application 202155

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELIQUISAPIXABANTABLET;ORAL2.5MGYesNo
002ELIQUISAPIXABANTABLET;ORAL5MGYesYes
003ELIQUISAPIXABANTABLET, FOR SUSPENSION;ORAL0.5MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0893ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0894ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3764ELIQUISapixabanE.R. Squibb & Sons, L.L.C.NDACurrent
50090-1436ELIQUISapixabanA-S Medication SolutionsNDACurrent
50090-1436ELIQUISapixabanA-S Medication SolutionsNDACurrent
50090-1436ELIQUISapixabanA-S Medication SolutionsNDACurrent
50090-1436ELIQUISapixabanA-S Medication SolutionsNDACurrent
50090-1436ELIQUISapixabanA-S Medication SolutionsNDACurrent
50090-1437ELIQUISapixabanA-S Medication SolutionsNDACurrent
50090-1437ELIQUISapixabanA-S Medication SolutionsNDACurrent
50090-1437ELIQUISapixabanA-S Medication SolutionsNDACurrent
55154-0612ELIQUISapixabanCardinal Health 107, LLCNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal Health 107, LLCNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal Health 107, LLCNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal Health 107, LLCNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0612ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal Health 107, LLCNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal Health 107, LLCNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal Health 107, LLCNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal HealthNDACurrent
55154-0613ELIQUISapixabanCardinal Health 107, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84395SUPPL 2025-12-12
84394SUPPL 2025-12-12
82023SUPPL 2025-04-28
82022SUPPL 2025-04-28
68973SUPPL2021-10-13
68969SUPPL2021-10-13
68968SUPPL2021-10-13
67148SUPPL2021-04-22
67146SUPPL2021-04-22
67134SUPPL2021-04-22
61079SUPPL2019-11-27
61078SUPPL2019-11-27
61076SUPPL2019-11-27
58977SUPPL2019-06-05
58970SUPPL2019-06-04
58969SUPPL2019-06-04
54836SUPPL2018-07-06
54801SUPPL2018-07-06
54762SUPPL2018-07-05
52630SUPPL2018-02-14
52565SUPPL2018-02-12
50563SUPPL2017-12-01
50532SUPPL2017-11-30
9979SUPPL2016-07-22
40134SUPPL2016-07-21
44989SUPPL2016-05-03
9980SUPPL2016-03-04
9978SUPPL2015-09-14
19077SUPPL2015-09-11
19076SUPPL2015-06-19
32197SUPPL2015-06-18
9976SUPPL2014-09-10
19075SUPPL2014-09-09
9977SUPPL2014-08-14
40133SUPPL2014-08-13
22876SUPPL2014-03-21
19073SUPPL2014-03-19
32195SUPPL2014-03-14
32194SUPPL2014-02-04
19072SUPPL2014-01-31
19074SUPPL2013-11-19
32196SUPPL2013-11-06
22875ORIG2013-02-13
9975ORIG2013-01-02
19071ORIG2012-12-31