FDA.reportPublic FDA data

Application 211962

Type
NDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 500MG BASE/100MLYesYes
002VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1GM BASE/200MLYesYes
003VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1.5GM BASE/300MLYesYes
004VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 2GM BASE/400MLYesYes
005VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 750MG BASE/150ML (EQ 5MG BASE/ML)YesYes
006VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1.25GM BASE/250ML (EQ 5MG BASE/ML)YesYes
007VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDESOLUTION;INTRAVENOUSEQ 1.75GM BASE/350ML (EQ 5MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70594-041VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-041VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-041VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-041VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-041VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-041VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-041VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-041VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-042VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-042VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-042VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-042VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-042VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-042VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-042VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-042VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-043VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-043VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-043VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-043VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-043VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-043VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-043VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-043VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-044VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-044VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-044VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-044VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-044VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-044VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-044VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-044VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-056VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-056VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-056VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-056VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-056VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-056VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-056VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-057VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-057VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-057VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-057VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-057VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-057VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-057VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-058VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-058VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-058VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-058VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-058VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-058VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent
70594-058VancomycinVancomycinXellia Pharmaceuticals USA LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82712SUPPL 2025-06-30
82701SUPPL 2025-06-30
82687SUPPL 2025-06-27
82674SUPPL 2025-06-27
67663SUPPL2021-06-02
67642SUPPL2021-06-01
66052SUPPL2021-02-01
66034SUPPL2021-02-01
64529SUPPL2020-09-08
64489SUPPL2020-09-04
59836ORIG2019-08-23
57729ORIG2019-02-21
57704ORIG2019-02-19