FDA.reportPublic FDA data

Application 204592

Type
NDA
Sponsor
ZYLA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZORVOLEXDICLOFENACCAPSULE;ORAL18MGYesNo
002ZORVOLEXDICLOFENACCAPSULE;ORAL35MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42211-203ZorvolexdiclofenacIroko Pharmaceuticals LLCNDACurrent
42211-203ZorvolexdiclofenacIroko Pharmaceuticals LLCNDACurrent
42211-204ZorvolexdiclofenacIroko Pharmaceuticals LLCNDACurrent
42211-204ZorvolexdiclofenacIroko Pharmaceuticals LLCNDACurrent
69344-203ZorvolexdiclofenacZyla Life Sciences US Inc.NDACurrent
69344-203ZorvolexdiclofenacEgalet US Inc.NDACurrent
69344-203ZorvolexdiclofenacZyla Life Sciences US Inc.NDACurrent
69344-204ZorvolexdiclofenacZyla Life Sciences US Inc.NDACurrent
69344-204ZorvolexdiclofenacEgalet US Inc.NDACurrent
69344-204ZorvolexdiclofenacZyla Life Sciences US Inc.NDACurrent
73480-242DICLOFENACDiclofenacTriVue Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80394SUPPL 2024-11-25
80393SUPPL 2024-11-25
80313SUPPL 2024-11-22
67360SUPPL2021-05-03
67359SUPPL2021-05-03
67285SUPPL2021-04-30
52767SUPPL2018-02-28
52766SUPPL2018-02-28
40397SUPPL2016-05-11
19575SUPPL2016-05-11
10362SUPPL2016-05-10
10361SUPPL2016-05-10
32570SUPPL2014-08-27
10360SUPPL2014-08-27
19574SUPPL2014-08-26
19573SUPPL2014-08-26
24472ORIG2014-03-26
22959ORIG2014-03-26
23515ORIG2013-10-24
19572ORIG2013-10-22
10359ORIG2013-10-22