FDA.reportPublic FDA data

Application 018332

Type
NDA
Sponsor
EGALET

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOCININDOMETHACINSUSPENSION;ORAL25MG/5MLYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42211-101INDOCINindomethacinIroko Pharmaceuticals, LLCNDACurrent
69344-101IndocinindomethacinEgalet US Inc.NDACurrent
69344-101IndocinindomethacinZyla Life Sciences US Inc.NDACurrent
69344-101IndocinindomethacinZyla Life Sciences US Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80341SUPPL 2024-11-25
80299SUPPL 2024-11-22
80298SUPPL 2024-11-22
67300SUPPL2021-04-30
67299SUPPL2021-04-30
67234SUPPL2021-04-29
58127SUPPL2019-03-28
58091SUPPL2019-03-27
58090SUPPL2019-03-27
14980SUPPL2016-05-12
900SUPPL2016-05-12
33479SUPPL2016-05-11
33478SUPPL2016-05-11
43608ORIG2009-11-19
33477SUPPL2009-04-03
11205SUPPL2007-02-02
899SUPPL2007-02-02
33476SUPPL2006-01-27
14979SUPPL2005-03-29