FDA.reportPublic FDA data

Application 207233

Type
NDA
Sponsor
ZYLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIVLODEXMELOXICAMCAPSULE;ORAL5MGYesNo
002VIVLODEXMELOXICAMCAPSULE;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42211-205VivlodexmeloxicamIroko Pharmaceuticals, LLNDACurrent
42211-205VivlodexmeloxicamIroko Pharmaceuticals, LLCNDACurrent
42211-206VivlodexmeloxicamIroko Pharmaceuticals, LLNDACurrent
42211-206VivlodexmeloxicamIroko Pharmaceuticals, LLCNDACurrent
69344-205VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-205VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-205VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-206VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-206VivlodexmeloxicamEgalet US Inc.NDACurrent
69344-206VivlodexmeloxicamEgalet US Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80400SUPPL 2024-11-25
80399SUPPL 2024-11-25
80317SUPPL 2024-11-22
67379SUPPL2021-05-03
67378SUPPL2021-05-03
67292SUPPL2021-04-30
23033ORIG2016-07-19
32851ORIG2015-10-28
40584ORIG2015-10-27