FDA.reportPublic FDA data

Application 206406

Type
NDA
Sponsor
VELOXIS PHARMS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ENVARSUS XRTACROLIMUSTABLET, EXTENDED RELEASE;ORALEQ 0.75MG BASEYesNo
002ENVARSUS XRTACROLIMUSTABLET, EXTENDED RELEASE;ORALEQ 1MG BASEYesNo
003ENVARSUS XRTACROLIMUSTABLET, EXTENDED RELEASE;ORALEQ 4MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68992-3010EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3010EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3010EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3010EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3010EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3040EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3040EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3040EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3040EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3040EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3075EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3075EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3075EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3075EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent
68992-3075EnvarsusTacrolimusVeloxis Pharmaceuticals, IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78104SUPPL 2024-04-09
78103SUPPL 2024-04-09
78095SUPPL 2024-04-09
75491SUPPL 2023-09-15
75471SUPPL 2023-09-15
64626SUPPL2020-09-21
64590SUPPL2020-09-17
56951SUPPL2018-12-21
56897SUPPL2018-12-20
56896SUPPL2018-12-20
46454ORIG2016-12-21
32806SUPPL2016-06-24
40547SUPPL2016-06-23
40546SUPPL2015-08-13
32805SUPPL2015-08-13
10569ORIG2015-07-14
40545ORIG2015-07-13
32804ORIG2014-11-04