FDA.reportPublic FDA data

Application 016295

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HYDREAHYDROXYUREACAPSULE;ORAL500MGYesYes
002DROXIAHYDROXYUREACAPSULE;ORAL200MGYesNo
003DROXIAHYDROXYUREACAPSULE;ORAL300MGYesNo
004DROXIAHYDROXYUREACAPSULE;ORAL400MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-0830HYDREAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0830HYDREAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0830HYDREAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0830HYDREAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0830HYDREAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6335DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6335DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6335DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6335DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6335DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6335DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6335DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6336DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6336DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6336DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6336DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6336DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6336DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6336DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6337DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6337DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6337DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6337DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6337DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6337DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
0003-6337DROXIAHYDROXYUREAE.R. Squibb & Sons, L.L.C.NDACurrent
61269-402DROXIAHYDROXYUREAH2-Pharma LLCNDACurrent
61269-403DROXIAHYDROXYUREAH2-Pharma LLCNDACurrent
61269-404DROXIAHYDROXYUREAH2-Pharma LLCNDACurrent
61269-835HYDREAHYDROXYUREAH2-Pharma LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78863SUPPL 2024-07-01
78865SUPPL 2024-06-24
76681SUPPL 2023-11-29
76677SUPPL 2023-11-29
76676SUPPL 2023-11-29
74466SUPPL 2023-06-09
74459SUPPL 2023-06-08
69883SUPPL2022-01-18
69880SUPPL2022-01-14
68310SUPPL2021-08-06
68300SUPPL2021-08-06
66219SUPPL2021-02-16
66175SUPPL2021-02-10
61375SUPPL2019-12-23
61353SUPPL2019-12-19
59423SUPPL2019-07-23
59422SUPPL2019-07-23
59413SUPPL2019-07-23
50788SUPPL2017-12-20
50787SUPPL2017-12-20
50775SUPPL2017-12-19
50774SUPPL2017-12-19
50773SUPPL2017-12-19
50772SUPPL2017-12-19
33158SUPPL2016-03-28
33157SUPPL2016-03-28
437SUPPL2016-03-25
436SUPPL2015-07-20
435SUPPL2015-07-20
33156SUPPL2015-07-17
10881SUPPL2015-07-17
33155SUPPL2012-01-31
10880SUPPL2012-01-31
434SUPPL2012-01-30
433SUPPL2012-01-30
33154SUPPL2010-05-17
12984SUPPL2010-05-12
33153SUPPL2006-09-20
432SUPPL2006-09-20
40712SUPPL2004-04-14
10879SUPPL2004-04-05
431SUPPL2004-03-02
10878SUPPL2003-07-08
430SUPPL2003-07-06
429SUPPL2001-04-04