Application 016059

Type
NDA
Sponsor
EGALET

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001INDOCININDOMETHACINCAPSULE;ORAL25MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002INDOCININDOMETHACINCAPSULE;ORAL50MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80364SUPPL 2024-11-25
80363SUPPL 2024-11-25
80338SUPPL 2024-11-25
67331SUPPL2021-05-03
67330SUPPL2021-05-03
67221SUPPL2021-04-29
58124SUPPL2019-03-28
58089SUPPL2019-03-27
58088SUPPL2019-03-27
33144SUPPL2016-05-11
12969SUPPL2016-05-11
10869SUPPL2016-05-11
414SUPPL2016-05-11
33143SUPPL2007-02-02
12968SUPPL2007-02-02
33142SUPPL2006-01-27
413SUPPL2005-03-29