FDA.reportPublic FDA data

Application 214985

Type
NDA
Sponsor
IDORSIA PHARMACEUTICALS LTD.

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001QUVIVIQDARIDOREXANTTABLET; ORAL25MGNoNo
002QUVIVIQDARIDOREXANTTABLET; ORAL50MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
80491-7825QUVIVIQDaridorexantIdorsia Pharmaceuticals LtdNDACurrent
80491-7825QUVIVIQDaridorexantIdorsia Pharmaceuticals LtdNDACurrent
80491-7850QUVIVIQDaridorexantIdorsia Pharmaceuticals LtdNDACurrent
80491-7850QUVIVIQDaridorexantIdorsia Pharmaceuticals LtdNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79797SUPPL 2024-10-01
79796SUPPL 2024-10-01
79795SUPPL 2024-10-01
79792SUPPL 2024-10-01
79791SUPPL 2024-10-01
79790SUPPL 2024-10-01
79788SUPPL 2024-10-01
76741SUPPL 2023-12-06
76010SUPPL 2023-10-31
76009SUPPL 2023-10-31
75994SUPPL 2023-10-31
75993SUPPL 2023-10-31
72589SUPPL2022-11-10
72588SUPPL2022-11-10
72583SUPPL2022-11-09
71542ORIG2022-07-13
70155ORIG2022-02-14
69833ORIG2022-01-11
69832ORIG2022-01-11
69829ORIG2022-01-11