Application 213436

Type: NDA
Sponsor: IMPEL NEUROPHARMA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DIHYDROERGOTAMINE MESYLATE	DIHYDROERGOTAMINE MESYLATE	SPRAY;TOPICAL	4MG/ML	No	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
N213436-001	TRUDHESA	DIHYDROERGOTAMINE MESYLATE	0.725MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2021-09-02

Orange Book patents#

Current patent rows page 1 of 1 · 6 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213436-001	9550036	2032-09-05		Drug product	2021-09-30
N213436-001	10507295	2032-12-25		Drug product	2021-09-30
N213436-001	10940278	2033-01-23		Drug product	2021-09-30
N213436-001	9919117	2033-03-17	U-3218	Drug product	2021-09-30
N213436-001	11266799	2036-11-05		Drug product	2022-03-28
N213436-001	11185497	2039-01-04	U-3218		2021-12-16

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213436-001	TRUDHESA	0.725MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2021-09-02	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 194 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	N213436-001	9550036	2032-09-05		Drug product	2021-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213436-001	10507295	2032-12-25		Drug product	2021-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213436-001	10940278	2033-01-23		Drug product	2021-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213436-001	9919117	2033-03-17	U-3218	Drug product	2021-09-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213436-001	11266799	2036-11-05		Drug product	2022-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213436-001	11185497	2039-01-04	U-3218		2021-12-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213436-001	9550036	2032-09-05		Drug product	2021-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213436-001	10507295	2032-12-25		Drug product	2021-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213436-001	10940278	2033-01-23		Drug product	2021-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213436-001	9919117	2033-03-17	U-3218	Drug product	2021-09-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213436-001	11266799	2036-11-05		Drug product	2022-03-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213436-001	11185497	2039-01-04	U-3218		2021-12-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213436-001	9550036	2032-09-05		Drug product	2021-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213436-001	10507295	2032-12-25		Drug product	2021-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213436-001	10940278	2033-01-23		Drug product	2021-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213436-001	9919117	2033-03-17	U-3218	Drug product	2021-09-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213436-001	11266799	2036-11-05		Drug product	2022-03-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213436-001	11185497	2039-01-04	U-3218		2021-12-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213436-001	9550036	2032-09-05		Drug product	2021-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213436-001	10507295	2032-12-25		Drug product	2021-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213436-001	10940278	2033-01-23		Drug product	2021-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213436-001	9919117	2033-03-17	U-3218	Drug product	2021-09-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213436-001	11266799	2036-11-05		Drug product	2022-03-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213436-001	11185497	2039-01-04	U-3218		2021-12-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213436-001	9550036	2032-09-05		Drug product	2021-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213436-001	10507295	2032-12-25		Drug product	2021-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213436-001	10940278	2033-01-23		Drug product	2021-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213436-001	9919117	2033-03-17	U-3218	Drug product	2021-09-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213436-001	11266799	2036-11-05		Drug product	2022-03-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213436-001	11185497	2039-01-04	U-3218		2021-12-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213436-001	9550036	2032-09-05		Drug product	2021-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213436-001	10507295	2032-12-25		Drug product	2021-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213436-001	10940278	2033-01-23		Drug product	2021-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213436-001	9919117	2033-03-17	U-3218	Drug product	2021-09-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213436-001	11266799	2036-11-05		Drug product	2022-03-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213436-001	11185497	2039-01-04	U-3218		2021-12-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213436-001	9550036	2032-09-05		Drug product	2021-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213436-001	10507295	2032-12-25		Drug product	2021-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213436-001	10940278	2033-01-23		Drug product	2021-09-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213436-001	9919117	2033-03-17	U-3218	Drug product	2021-09-30	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213436-001	NP	2024-09-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213436-001	NP	2024-09-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213436-001	NP	2024-09-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213436-001	NP	2024-09-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213436-001	NP	2024-09-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213436-001	NP	2024-09-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213436-001	NP	2024-09-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213436-001	NP	2024-09-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213436-001	NP	2024-09-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213436-001	NP	2024-09-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213436-001	NP	2024-09-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213436-001	NP	2024-09-02	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213436-001	NP	2024-09-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213436-001	NP	2024-09-02	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213436-001	NP	2024-09-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213436-001	NP	2024-09-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213436-001	NP	2024-09-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213436-001	NP	2024-09-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213436-001	NP	2024-09-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213436-001	NP	2024-09-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213436-001	NP	2024-09-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213436-001	NP	2024-09-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213436-001	NP	2024-09-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213436-001	NP	2024-09-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213436-001	NP	2024-09-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213436-001	NP	2024-09-02	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213436-001	NP	2024-09-02	`cb3db0bc1861…`

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
Trudhesa	DIHYDROERGOTAMINE MESYLATE	Impel Pharmaceuticals LLC	b81397b0-910d-4eb4-8fee-a9a3c9d94d63	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 213436 application number: NDA213436 ndc (product): 77530-725

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
77530-725	Trudhesa	Dihydroergotamine mesylate	Impel Pharmaceuticals Inc.	NDA	Current
77530-725	Trudhesa	Dihydroergotamine mesylate	Impel NeuroPharma, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
71873	ORIG	2022-08-23
68579	ORIG	2021-09-10
68578	ORIG	2021-09-10
68548	ORIG	2021-09-07