Application 214697

Type: NDA
Sponsor: ARS PHARMS OPERATION

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NEFFY	EPINEPHRINE	SPRAY;NASAL	2MG/SPRAY	Yes	Yes
002	NEFFY	EPINEPHRINE	SPRAY;NASAL	1MG/SPRAY	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N214697-001	NEFFY	EPINEPHRINE	2MG/SPRAY	SPRAY / NASAL		RLD, RS	2024-08-09
N214697-002	NEFFY	EPINEPHRINE	1MG/SPRAY	SPRAY / NASAL		RLD, RS	2025-03-05

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N214697-001	10576156	2038-02-06		Drug product	2024-08-28
N214697-001	11173209	2038-02-06	U-3979		2024-08-28
N214697-001	10682414	2039-02-06	U-3979		2024-08-28
N214697-001	11191838	2039-02-06	U-3979	Drug product	2024-08-28
N214697-001	11717571	2039-02-06	U-3979		2024-08-28
N214697-001	11744895	2039-02-06	U-3979		2024-08-28
N214697-001	11918655	2039-02-06	U-3979	Drug product	2024-08-28
N214697-001	12324838	2039-02-06		Drug product	2025-06-20
N214697-002	10576156	2038-02-06		Drug product	2025-04-03
N214697-002	11173209	2038-02-06	U-3979		2025-04-03
N214697-002	10682414	2039-02-06	U-3979		2025-04-03
N214697-002	11191838	2039-02-06	U-3979	Drug product	2025-04-03
N214697-002	11717571	2039-02-06	U-3979		2025-04-03
N214697-002	11744895	2039-02-06	U-3979		2025-04-03
N214697-002	11918655	2039-02-06	U-3979		2025-04-03
N214697-002	12324838	2039-02-06		Drug product	2025-06-20

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
2026-09-14 22:38:34	2026-08	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214697-001	NEFFY	2MG/SPRAY	SPRAY / NASAL	RLD, RS	2024-08-09	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214697-002	NEFFY	1MG/SPRAY	SPRAY / NASAL	RLD, RS	2025-03-05	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 4 · 145 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N214697-001	10576156	2038-02-06		Drug product	2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11173209	2038-02-06	U-3979		2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	10682414	2039-02-06	U-3979		2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11191838	2039-02-06	U-3979	Drug product	2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11717571	2039-02-06	U-3979		2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11744895	2039-02-06	U-3979		2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	11918655	2039-02-06	U-3979	Drug product	2024-08-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-001	12324838	2039-02-06		Drug product	2025-06-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	10576156	2038-02-06		Drug product	2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11173209	2038-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	10682414	2039-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11191838	2039-02-06	U-3979	Drug product	2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11717571	2039-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11744895	2039-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	11918655	2039-02-06	U-3979		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N214697-002	12324838	2039-02-06		Drug product	2025-06-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N214697-001	10576156	2038-02-06		Drug product	2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11173209	2038-02-06	U-3979		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	10682414	2039-02-06	U-3979		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11191838	2039-02-06	U-3979	Drug product	2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11717571	2039-02-06	U-3979		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11744895	2039-02-06	U-3979		2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	11918655	2039-02-06	U-3979	Drug product	2024-08-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-001	12324838	2039-02-06		Drug product	2025-06-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	10576156	2038-02-06		Drug product	2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11173209	2038-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	10682414	2039-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11191838	2039-02-06	U-3979	Drug product	2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11717571	2039-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11744895	2039-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	11918655	2039-02-06	U-3979		2025-04-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N214697-002	12324838	2039-02-06		Drug product	2025-06-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N214697-001	10576156	2038-02-06		Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11173209	2038-02-06	U-3979		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	10682414	2039-02-06	U-3979		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11191838	2039-02-06	U-3979	Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11717571	2039-02-06	U-3979		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11744895	2039-02-06	U-3979		2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	11918655	2039-02-06	U-3979	Drug product	2024-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214697-001	12324838	2039-02-06		Drug product	2025-06-20	`011fe1cb6892…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
neffy	EPINEPHRINE	Sportpharm LLC	2052f9db-7d76-443b-b702-b6b499f9a4b8	2026-04-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214697 application number: NDA214697
neffy	EPINEPHRINE	ARS Pharmaceuticals Operations, Inc.	a1758142-a905-401d-8961-05829f51023a	2026-04-09	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214697 application number: NDA214697
neffy	EPINEPHRINE	Medical Purchasing Solutions, LLC	2d4063e8-f56c-6902-e063-6294a90a0d40	2025-02-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214697 application number: NDA214697

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85567	SUPPL	2026-04-10
81445	SUPPL	2026-04-07
85566	SUPPL	2026-03-30
85177	SUPPL	2026-02-27
83945	SUPPL	2025-10-28
83937	SUPPL	2025-10-27
81950	ORIG	2025-04-11
81459	SUPPL	2025-03-06
79374	ORIG	2024-08-12
79366	ORIG	2024-08-12