FDA.reportPublic FDA data

Application 050580

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AZACTAMAZTREONAMINJECTABLE;INJECTION500MG/VIALNoNo
002AZACTAMAZTREONAMINJECTABLE;INJECTION1GM/VIALYesYes
003AZACTAMAZTREONAMINJECTABLE;INJECTION2GM/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-2560AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2560AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2560AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2560AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2560AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2570AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2570AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2570AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2570AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent
0003-2570AZACTAMAZTREONAME.R. Squibb & Sons, L.L.C.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67112SUPPL2021-04-19
67102SUPPL2021-04-19
57690ORIG2019-02-15
54677SUPPL2018-06-21
54638SUPPL2018-06-21
7841SUPPL2013-06-18
38999SUPPL2013-06-17
17895SUPPL2008-01-24
7840SUPPL2008-01-24
7839SUPPL2004-12-30
7838SUPPL2002-03-25