Home Applications 211243 Application 211243
Type NDA
Sponsor JANSSEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 SPRAVATO ESKETAMINE HYDROCHLORIDE SPRAY;NASAL EQ 28MG BASE Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N211243-001 SPRAVATO ESKETAMINE HYDROCHLORIDE EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05
Orange Book patents# Current patent rows page 1 of 1 · 25 matching rows.
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 1 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N211243-001 I-959 2028-01-17
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N211243-001 SPRAVATO EQ 28MG BASE SPRAY / NASAL RLD, RS 2019-03-05 cb3db0bc1861…
Observed Orange Book patent history# Patent history page 1 of 13 · 496 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N211243-001 9592207 2027-03-20 U-2502 2019-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 9592207 2027-03-20 U-4112 2019-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 8785500 2033-03-05 U-2502 2019-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 8785500 2033-03-05 U-4112 2019-04-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11446260 2034-03-14 U-4118 2022-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11446260 2034-03-14 U-4119 2022-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11446260 2034-03-14 U-3444 2022-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11446260 2034-03-14 U-3445 2022-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11446260 2034-03-14 U-3446 2022-10-14 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 10869844 2035-09-10 U-4113 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 10869844 2035-09-10 U-4114 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 10869844 2035-09-10 U-3035 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 10869844 2035-09-10 U-3034 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 10869844 2035-09-10 U-3036 2021-01-15 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11173134 2035-09-10 U-4115 2021-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11173134 2035-09-10 U-3536 2021-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11173134 2035-09-10 U-3257 2021-12-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11311500 2035-09-10 U-4116 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11311500 2035-09-10 U-4117 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11311500 2035-09-10 U-3034 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11311500 2035-09-10 U-3036 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11311500 2035-09-10 U-3035 2022-05-26 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11883526 2040-02-18 U-4120 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11883526 2040-02-18 U-3812 2024-02-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N211243-001 11883526 2040-02-18 U-3813 2024-02-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 9592207 2027-03-20 U-2502 2019-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 9592207 2027-03-20 U-4112 2019-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 8785500 2033-03-05 U-2502 2019-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 8785500 2033-03-05 U-4112 2019-04-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 11446260 2034-03-14 U-4118 2022-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 11446260 2034-03-14 U-4119 2022-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 11446260 2034-03-14 U-3444 2022-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 11446260 2034-03-14 U-3445 2022-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 11446260 2034-03-14 U-3446 2022-10-14 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 10869844 2035-09-10 U-4113 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 10869844 2035-09-10 U-4114 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 10869844 2035-09-10 U-3035 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 10869844 2035-09-10 U-3034 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 10869844 2035-09-10 U-3036 2021-01-15 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N211243-001 11173134 2035-09-10 U-4115 2021-12-16 31067a03dcf5…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 60 observed states.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Spravato ESKETAMINE HYDROCHLORIDE Janssen Pharmaceuticals Inc. d81a6a79-a74a-44b7-822c-0dfa3036eaed 2026-03-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 211243 application number: NDA211243 ndc (product): 50458-028
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50458-028 Spravato Esketamine Hydrochloride Janssen Pharmaceuticals Inc. NDA Current 50458-028 Spravato Esketamine Hydrochloride Janssen Pharmaceuticals Inc. NDA Current 50458-028 Spravato Esketamine Hydrochloride Janssen Pharmaceuticals Inc. NDA Current 50458-028 Spravato Esketamine Hydrochloride Janssen Pharmaceuticals Inc. NDA Current 50458-028 Spravato Esketamine Hydrochloride Janssen Pharmaceuticals Inc. NDA Current 50458-028 Spravato Esketamine Hydrochloride Janssen Pharmaceuticals Inc. NDA Current