Application 209963

Type: NDA
Sponsor: GENUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GOPRELTO	COCAINE HYDROCHLORIDE	SOLUTION;NASAL	4%	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
N209963-001	GOPRELTO	COCAINE HYDROCHLORIDE	4%	SOLUTION / NASAL		RLD, RS	2017-12-14

Orange Book patents#

Current patent rows page 1 of 1 · 15 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209963-001	10016407	2037-02-07	U-2329		2018-07-20
N209963-001	10149843	2037-02-07	U-2478		2019-01-10
N209963-001	10149843	2037-02-07	U-2479		2019-01-10
N209963-001	10231961	2037-02-07		Drug product	2019-04-15
N209963-001	10413505	2037-02-07	U-2479		2019-10-16
N209963-001	10420760	2037-02-07	U-2478		2019-10-23
N209963-001	10857095	2037-02-07	U-3014		2021-01-06
N209963-001	10894012	2037-02-07	U-3014		2021-02-11
N209963-001	10933060	2037-02-07	U-3014		2021-04-01
N209963-001	10973811	2037-02-07	U-2226		2021-05-13
N209963-001	10987347	2037-02-07	U-2225		2021-05-27
N209963-001	11040032	2037-02-07		Drug product	2021-12-09
N209963-001	9867815	2037-02-07	U-2225		2018-01-31
N209963-001	9867815	2037-02-07	U-2226		2018-01-31
N209963-001	9867815	2037-02-07	U-2227		2018-01-31

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 · 43 observed 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	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209963-001	GOPRELTO	4%	SOLUTION / NASAL	RLD, RS	2017-12-14	`f41ea6bd6efb…`

Observed Orange Book patent history#

Patent history page 1 of 15 · 596 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	N209963-001	10016407	2037-02-07	U-2329		2018-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10149843	2037-02-07	U-2479		2019-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10149843	2037-02-07	U-2478		2019-01-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10231961	2037-02-07		Drug product	2019-04-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10413505	2037-02-07	U-2479		2019-10-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10420760	2037-02-07	U-2478		2019-10-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10857095	2037-02-07	U-3014		2021-01-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10894012	2037-02-07	U-3014		2021-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10933060	2037-02-07	U-3014		2021-04-01	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10973811	2037-02-07	U-2226		2021-05-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	10987347	2037-02-07	U-2225		2021-05-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	11040032	2037-02-07		Drug product	2021-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	9867815	2037-02-07	U-2225		2018-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	9867815	2037-02-07	U-2226		2018-01-31	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209963-001	9867815	2037-02-07	U-2227		2018-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209963-001	10016407	2037-02-07	U-2329		2018-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10149843	2037-02-07	U-2479		2019-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10149843	2037-02-07	U-2478		2019-01-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10231961	2037-02-07		Drug product	2019-04-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10413505	2037-02-07	U-2479		2019-10-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10420760	2037-02-07	U-2478		2019-10-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10857095	2037-02-07	U-3014		2021-01-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10894012	2037-02-07	U-3014		2021-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10933060	2037-02-07	U-3014		2021-04-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10973811	2037-02-07	U-2226		2021-05-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	10987347	2037-02-07	U-2225		2021-05-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	11040032	2037-02-07		Drug product	2021-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	9867815	2037-02-07	U-2225		2018-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	9867815	2037-02-07	U-2226		2018-01-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209963-001	9867815	2037-02-07	U-2227		2018-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10016407	2037-02-07	U-2329		2018-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10149843	2037-02-07	U-2479		2019-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10149843	2037-02-07	U-2478		2019-01-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10231961	2037-02-07		Drug product	2019-04-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10413505	2037-02-07	U-2479		2019-10-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10420760	2037-02-07	U-2478		2019-10-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10857095	2037-02-07	U-3014		2021-01-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10894012	2037-02-07	U-3014		2021-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10933060	2037-02-07	U-3014		2021-04-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209963-001	10973811	2037-02-07	U-2226		2021-05-13	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209963-001	NCE	2022-12-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209963-001	NCE	2022-12-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209963-001	NCE	2022-12-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209963-001	NCE	2022-12-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209963-001	NCE	2022-12-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209963-001	NCE	2022-12-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N209963-001	NCE	2022-12-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N209963-001	NCE	2022-12-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N209963-001	NCE	2022-12-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209963-001	NCE	2022-12-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209963-001	NCE	2022-12-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209963-001	NCE	2022-12-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209963-001	NCE	2022-12-14	`ea99ee380514…`
2023-01-26 05:58 UTC	2023-01	N209963-001	NCE	2022-12-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N209963-001	NCE	2022-12-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N209963-001	NCE	2022-12-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209963-001	NCE	2022-12-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209963-001	NCE	2022-12-14	`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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Goprelto	COCAINE HYDROCHLORIDE	LXO US Inc.	0f897764-fe30-090a-e063-6294a90af106	2024-11-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209963 application number: NDA209963
COCAINE HYDROCHLORIDE	COCAINE HYDROCHLORIDE	LXO US INC.	0fb0298f-9756-26e8-e063-6294a90ae8f2	2024-01-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209963 application number: NDA209963

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64950-359	GOPRELTO	cocaine hydrochloride	Genus Lifesciences Inc.	NDA	Current
64950-359	GOPRELTO	cocaine hydrochloride	Genus Lifesciences Inc.	NDA	Current
64950-362	cocaine hydrochloride	cocaine hydrochloride	Genus Lifesciences Inc.	NDA AUTHORIZED GENERIC	Current
64950-362	cocaine hydrochloride	cocaine hydrochloride	Genus Lifesciences Inc.	NDA AUTHORIZED GENERIC	Current
64950-362	cocaine hydrochloride	cocaine hydrochloride	Genus Lifesciences Inc.	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74801	SUPPL	2023-07-20
74785	SUPPL	2023-07-19
72761	SUPPL	2022-12-01
72747	SUPPL	2022-11-29
55385	ORIG	2018-09-05
53874	ORIG	2018-04-30
50780	ORIG	2017-12-20