FDA.reportPublic FDA data

Application 204768

Type
NDA
Sponsor
GENUS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TIVORBEXINDOMETHACINCAPSULE;ORAL20MGYesNo
002TIVORBEXINDOMETHACINCAPSULE;ORAL40MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42211-201TivorbexindomethacinIroko Pharmaceuticals, LLCNDACurrent
42211-202TivorbexindomethacinIroko Pharmaceuticals, LLCNDACurrent
69344-201TivorbexindomethacinEgalet US Inc.NDACurrent
69344-202TivorbexindomethacinEgalet US Inc.NDACurrent
69597-350TivorbexindomethacinBasiemNDACurrent
69597-350TivorbexindomethacinBasiemNDACurrent
69597-350TivorbexindomethacinBasiemNDACurrent
69597-350TivorbexindomethacinBasiemNDACurrent
73308-349IndomethacinindomethacinAyuraxNDACurrent
73308-349IndomethacinindomethacinAyuraxNDACurrent
73308-349IndomethacinindomethacinAyuraxNDACurrent
73308-349IndomethacinindomethacinAyuraxNDACurrent
73308-350IndomethacinindomethacinAyuraxNDACurrent
73308-350IndomethacinindomethacinAyuraxNDACurrent
73308-350IndomethacinindomethacinAyuraxNDACurrent
73308-350IndomethacinindomethacinAyuraxNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
67375SUPPL2021-05-03
67374SUPPL2021-05-03
67288SUPPL2021-04-30
58129SUPPL2019-03-28
58078SUPPL2019-03-26
58075SUPPL2019-03-26
43974SUPPL2016-05-18
19597SUPPL2016-05-11
19596SUPPL2016-05-11
10393SUPPL2016-05-10
10392SUPPL2016-05-10
44909ORIG2014-08-07
22965ORIG2014-08-07
10391ORIG2014-02-26
19595ORIG2014-02-25