FDA.reportPublic FDA data

Application 211243

Type
NDA
Sponsor
JANSSEN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SPRAVATOESKETAMINE HYDROCHLORIDESPRAY;NASALEQ 28MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50458-028SpravatoEsketamine HydrochlorideJanssen Pharmaceuticals Inc.NDACurrent
50458-028SpravatoEsketamine HydrochlorideJanssen Pharmaceuticals Inc.NDACurrent
50458-028SpravatoEsketamine HydrochlorideJanssen Pharmaceuticals Inc.NDACurrent
50458-028SpravatoEsketamine HydrochlorideJanssen Pharmaceuticals Inc.NDACurrent
50458-028SpravatoEsketamine HydrochlorideJanssen Pharmaceuticals Inc.NDACurrent
50458-028SpravatoEsketamine HydrochlorideJanssen Pharmaceuticals Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85729SUPPL 2026-04-21
84831SUPPL 2026-01-26
83724SUPPL 2025-10-10
83018SUPPL 2025-08-01
82200SUPPL 2025-05-19
82124SUPPL 2025-05-01
82041SUPPL 2025-04-29
82040SUPPL 2025-04-29
81764SUPPL 2025-03-28
80902SUPPL 2025-02-04
80895SUPPL 2025-02-04
80805SUPPL 2025-01-02
80174SUPPL 2024-11-05
80151SUPPL 2024-11-05
75861SUPPL 2023-10-19
75847SUPPL 2023-10-19
73287SUPPL2023-01-25
72841SUPPL2022-12-09
69814SUPPL2022-01-05
64192SUPPL2020-08-03
64191SUPPL2020-08-03
64179SUPPL2020-08-03
61874SUPPL2020-02-12
61873SUPPL2020-02-12
61869SUPPL2020-02-12
59219ORIG2019-07-02
59174SUPPL2019-06-26
58642SUPPL2019-05-13
58637SUPPL2019-05-10
58636SUPPL2019-05-10
58220ORIG2019-04-05
57911ORIG2019-03-06
57910ORIG2019-03-06
57909ORIG2019-03-06