Application 217722

Type: NDA
Sponsor: HARM REDUCTION THERP

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIVIVE	NALOXONE HYDROCHLORIDE	SPRAY, METERED;NASAL	3MG/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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N217722-001	RIVIVE	NALOXONE HYDROCHLORIDE	3MG/SPRAY	SPRAY, METERED / NASAL		RLD, RS	2023-07-28

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217722-001	11020343	2032-05-11	U-3671		2023-08-25
N217722-001	11806428	2032-05-11		Drug product	2024-01-25
N217722-001	12458591	2032-05-11	U-3671		2025-11-26

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	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`9b2671bbb829…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N217722-001	RIVIVE	3MG/SPRAY	SPRAY, METERED / NASAL	RLD, RS	2023-07-28	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 46 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	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217722-001	12458591	2032-05-11	U-3671		2025-11-26	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217722-001	12458591	2032-05-11	U-3671		2025-11-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217722-001	12458591	2032-05-11	U-3671		2025-11-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217722-001	12458591	2032-05-11	U-3671		2025-11-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217722-001	11020343	2032-05-11	U-3671		2023-08-25	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217722-001	11806428	2032-05-11		Drug product	2024-01-25	`1c564ffb4f44…`

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
RiVive	NALOXONE HYDROCHLORIDE	Harm Reduction Therapeutics, Inc.	1c4f1b9d-1c70-4666-a90e-2f5d2c670d4d	2026-01-13	Warnings	Exact identifier application applno (NDA): 217722 application number: NDA217722

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
75333	ORIG	2023-09-01
74922	ORIG	2023-07-28
74921	ORIG	2023-07-28