FDA.reportPublic FDA data

Application 217415

Type
NDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPTOMYCINDAPTOMYCINPOWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER350MGNoNo
002DAPTOMYCINDAPTOMYCINPOWDER, FOR INJECTION SOLUTION, LYOPHILIZED POWDER500MGNoNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82457SUPPL 2025-06-03
82147SUPPL 2025-04-30
81120SUPPL 2025-02-07
81102SUPPL 2025-02-06
75520ORIG 2023-09-20
73343ORIG2023-01-31
73342ORIG2023-01-31