FDA.reportPublic FDA data

Application 214155

Type
NDA
Sponsor
MELINTA THERAP

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KIMYRSAORITAVANCIN DIPHOSPHATEPOWDER;INTRAVENOUSEQ 1.2GM BASE/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70842-225Kimyrsaoritavancin diphosphateMelinta Therapeutics, LLCNDACurrent
70842-225Kimyrsaoritavancin diphosphateMelinta Therapeutics, LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82072SUPPL 2025-04-29
68199SUPPL2021-07-27
68186SUPPL2021-07-26
66790ORIG2021-03-16
66786ORIG2021-03-16