Home Applications 209388 Application 209388
Type NDA
Sponsor EVOKE PHARMA INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 GIMOTI METOCLOPRAMIDE SPRAY;NASAL 15MG Yes No
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 N209388-001 GIMOTI METOCLOPRAMIDE HYDROCHLORIDE EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19
Orange Book patents# Current patent rows page 1 of 1 · 7 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N209388-001 11020361 2029-12-22 U-2843 2021-06-03 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 N209388-001 12377064 2038-11-17 U-2843 2025-08-05
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.
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 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N209388-001 GIMOTI EQ 15MG BASE/SPRAY SPRAY, METERED / NASAL RLD, RS 2020-06-19 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 4 · 131 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 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N209388-001 12377064 2038-11-17 U-2843 2025-08-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N209388-001 12377064 2038-11-17 U-2843 2025-08-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N209388-001 12377064 2038-11-17 U-2843 2025-08-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 12194008 2029-12-22 U-2843 2025-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 12194009 2029-12-22 U-2843 2025-01-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N209388-001 8334281 2030-05-16 U-2843 Drug product 2020-06-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209388-001 11020361 2029-12-22 U-2843 2021-06-03 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209388-001 11628150 2029-12-22 U-2843 Drug product 2023-04-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N209388-001 11813231 2029-12-22 U-2843 Drug product 2023-11-16 2680178bc6a6…
Observed Orange Book exclusivity history# 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 GIMOTI METOCLOPRAMIDE HYDROCHLORIDE Evoke Pharma, Inc. 95269b1f-779c-4ca0-9f86-e74e677f9900 2026-02-20 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 209388 application number: NDA209388 ndc (product): 72089-307
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 2 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 72089-307 GIMOTI METOCLOPRAMIDE HYDROCHLORIDE Evoke Pharma, Inc. NDA Current 72089-307 GIMOTI METOCLOPRAMIDE HYDROCHLORIDE Evoke Pharma, Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 85003 SUPPL 2026-02-11 85002 SUPPL 2026-02-11 84975 SUPPL 2026-02-10 67169 ORIG 2021-04-26 65932 SUPPL 2021-01-19 65913 SUPPL 2021-01-15 65912 SUPPL 2021-01-15 63667 ORIG 2020-06-23 63664 ORIG 2020-06-23 63663 ORIG 2020-06-23