FDA.reportPublic FDA data

Application 021986

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPRYCELDASATINIBTABLET;ORAL20MGYesNo
002SPRYCELDASATINIBTABLET;ORAL50MGYesNo
003SPRYCELDASATINIBTABLET;ORAL70MGYesNo
004SPRYCELDASATINIBTABLET;ORAL100MGYesYes
005SPRYCELDASATINIBTABLET;ORAL80MGYesNo
006SPRYCELDASATINIBTABLET;ORAL140MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-0524SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0524SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0524SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0524SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0524SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0524SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0524SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0527SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0527SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0527SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0527SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0527SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0527SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0527SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0528SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0528SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0528SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0528SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0528SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0528SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0528SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0852SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0852SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0852SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0852SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0852SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0852SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0852SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0855SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0855SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0855SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0855SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0855SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0855SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0855SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0857SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0857SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0857SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0857SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0857SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0857SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent
0003-0857SPRYCELdasatinibE.R. Squibb & Sons, L.L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79280SUPPL 2024-08-02
79266SUPPL 2024-08-02
73440SUPPL 2023-02-09
73422SUPPL 2023-02-09
67986SUPPL2021-06-30
67984SUPPL2021-06-30
57067SUPPL2018-12-30
57019SUPPL2018-12-26
56690SUPPL2018-12-07
56539SUPPL2018-11-23
50427SUPPL2017-11-15
50407SUPPL2017-11-14
49412SUPPL2017-08-15
49354SUPPL2017-08-14
45490SUPPL2016-09-30
45426SUPPL2016-09-29
28986SUPPL2015-08-14
6597SUPPL2015-08-14
38004SUPPL2015-08-13
16697SUPPL2015-08-13
38003SUPPL2014-05-12
6596SUPPL2014-04-14
28985SUPPL2013-06-18
38002SUPPL2013-06-17
28984SUPPL2011-10-13
6595SUPPL2011-10-13
38001SUPPL2011-10-12
16696SUPPL2011-10-12
42369SUPPL2011-09-22
21896SUPPL2011-09-22
28983SUPPL2010-11-03
6594SUPPL2010-11-03
38000SUPPL2010-10-28
16695SUPPL2010-10-28
28982SUPPL2010-08-09
37999SUPPL2010-07-31
6593SUPPL2009-05-29
16694SUPPL2009-05-25
6592SUPPL2008-06-03
28981SUPPL2007-11-19
6591SUPPL2007-11-19
37998SUPPL2007-11-13
21895ORIG2006-09-06
28980ORIG2006-07-03
16693ORIG2006-07-03
62938SUPPL1900-01-01
62937SUPPL1900-01-01