FDA.reportPublic FDA data

Application 206352

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REYATAZATAZANAVIR SULFATEPOWDER;ORALEQ 50MG BASE/PACKETYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-3638REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3638REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3638REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3638REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3638REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80541SUPPL 2024-12-10
80531SUPPL 2024-12-06
76537SUPPL 2023-11-08
76525SUPPL 2023-11-08
64689SUPPL2020-09-25
64681SUPPL2020-09-25
53768SUPPL2018-04-20
53741SUPPL2018-04-19
50166SUPPL2017-10-24
50141SUPPL2017-10-23
48541SUPPL2017-05-25
48527SUPPL2017-05-25
45338SUPPL2016-09-20
45306SUPPL2016-09-15
19718SUPPL2015-12-10
32801SUPPL2015-09-28
24514ORIG2015-04-07
23019ORIG2015-04-07
40541SUPPL2015-04-02
10564SUPPL2015-04-01
19717ORIG2014-06-03
10563ORIG2014-06-03
51748SUPPL1900-01-01
51745SUPPL1900-01-01
51744ORIG1900-01-01
51741ORIG1900-01-01
51740SUPPL1900-01-01
51737ORIG1900-01-01