FDA.reportPublic FDA data

Application 211230

Type
NDA
Sponsor
JAZZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUNOSISOLRIAMFETOL HYDROCHLORIDETABLET;ORALEQ 75MG BASEYesNo
002SUNOSISOLRIAMFETOL HYDROCHLORIDETABLET;ORALEQ 150MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
68727-350SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-350SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-350SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-350SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-350SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-350SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-351SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-351SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-351SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-351SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-351SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
68727-351SUNOSIsolriamfetolJazz Pharmaceuticals, Inc.NDACurrent
81968-350SUNOSIsolriamfetolAxsome Therapeutics, Inc.NDACurrent
81968-350SUNOSIsolriamfetolAxsome Therapeutics, Inc.NDACurrent
81968-351SUNOSIsolriamfetolAxsome Therapeutics, Inc.NDACurrent
81968-351SUNOSIsolriamfetolAxsome Therapeutics, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74665SUPPL 2023-06-29
74664SUPPL 2023-06-29
74653SUPPL 2023-06-29
72773SUPPL2022-12-05
72763SUPPL2022-12-02
69136SUPPL2021-10-27
69063SUPPL2021-10-21
68944ORIG2021-10-08
68943ORIG2021-10-08
58060ORIG2020-03-20
58052ORIG2020-03-20
58051ORIG2020-03-20
58050ORIG2020-03-20
58049ORIG2020-03-20
58048ORIG2020-03-20
60470SUPPL2019-10-09
60273SUPPL2019-10-07
58467ORIG2019-04-29
58466ORIG2019-04-29