FDA.reportPublic FDA data

Application 208562

Type
NDA
Sponsor
XELLIA PHARMS APS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VORICONAZOLEVORICONAZOLEPOWDER;INTRAVENOUS200MG/VIALNoNo
002VORICONAZOLEVORICONAZOLEINJECTABLE;INJECTION200MGYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
39822-1077VoriconazoleVoriconazoleX-GEN Pharmaceuticals, Inc.NDACurrent
39822-1077VoriconazolevoriconazoleX-Gen Pharmaceuticals IncNDACurrent
39822-1077VoriconazolevoriconazoleXGen Pharmaceuticals DJB, Inc.NDACurrent
39822-1077VoriconazoleVoriconazoleXGen Pharmaceuticals DJB, Inc.NDACurrent
39822-1077VoriconazoleVoriconazoleXGen Pharmaceuticals DJB, Inc.NDACurrent
70594-067VoriconazoleVoriconazoleXellia Pharmaceuticals USA LLCNDACurrent
70594-067VoriconazoleVoriconazoleXellia Pharmaceuticals USA LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
82028SUPPL 2025-04-28
81958SUPPL 2025-04-24
73088SUPPL2023-01-04
73082SUPPL2023-01-04
71829SUPPL2022-08-17
71815SUPPL2022-08-17
69716SUPPL2021-12-21
69629SUPPL2021-12-19
54472ORIG2018-06-07
53632SUPPL2018-04-09
53457SUPPL2018-03-27
48322ORIG2017-03-14
48321ORIG2017-03-10