FDA.reportPublic FDA data

Application 209949

Type
NDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPTOMYCINDAPTOMYCINPOWDER;IV (INFUSION)350MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0409-5933DaptomycinDaptomycinHospira Inc.NDACurrent
0409-5933DaptomycinDAPTOMYCINHospira Inc.NDACurrent
45932-0039DaptomycinDaptomycinXellia Pharmaceuticals USA, LLCNDACurrent
63323-585DaptomycinDaptomycinFresenius Kabi USA, LLCNDACurrent
63323-585DaptomycinDaptomycinFresenius Kabi USA, LLCNDACurrent
70594-053DaptomycinDaptomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-053DaptomycinDaptomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-053DaptomycinDaptomycinXellia Pharmaceuticals USA LLCNDACurrent
72572-100DaptomycinDaptomycinCivica, Inc.NDACurrent
72572-100DaptomycinDaptomycinCivica, Inc.NDACurrent
72572-100DaptomycinDaptomycinCivica, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82144SUPPL 2025-05-05
82288SUPPL 2025-04-30
75698SUPPL 2023-10-10
75684SUPPL 2023-10-10
67433SUPPL2021-05-07
67428SUPPL2021-05-06
67427SUPPL2021-05-06
66244SUPPL2021-02-17
60043SUPPL2019-09-19
60036SUPPL2019-09-19
52675ORIG2018-02-20
50180ORIG2017-10-25
50130ORIG2017-10-23