Application 210875

Type: NDA
Sponsor: SUNOVION PHARMS INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	KYNMOBI	APOMORPHINE HYDROCHLORIDE	FILM;SUBLINGUAL	10MG	Yes	No
002	KYNMOBI	APOMORPHINE HYDROCHLORIDE	FILM;SUBLINGUAL	15MG	Yes	No
003	KYNMOBI	APOMORPHINE HYDROCHLORIDE	FILM;SUBLINGUAL	20MG	Yes	No
004	KYNMOBI	APOMORPHINE HYDROCHLORIDE	FILM;SUBLINGUAL	25MG	Yes	No
005	KYNMOBI	APOMORPHINE HYDROCHLORIDE	FILM;SUBLINGUAL	30MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N210875-001	KYNMOBI	APOMORPHINE HYDROCHLORIDE	10MG	FILM / SUBLINGUAL	RLD	2020-05-21
N210875-002	KYNMOBI	APOMORPHINE HYDROCHLORIDE	15MG	FILM / SUBLINGUAL	RLD	2020-05-21
N210875-003	KYNMOBI	APOMORPHINE HYDROCHLORIDE	20MG	FILM / SUBLINGUAL	RLD	2020-05-21
N210875-004	KYNMOBI	APOMORPHINE HYDROCHLORIDE	25MG	FILM / SUBLINGUAL	RLD	2020-05-21
N210875-005	KYNMOBI	APOMORPHINE HYDROCHLORIDE	30MG	FILM / SUBLINGUAL	RLD	2020-05-21

Orange Book patents#

Current patent rows page 1 of 1 · 60 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N210875-001	10821074	2029-08-07		Drug product	2020-11-12
N210875-001	10420763	2030-06-11	U-2825	Drug product	2020-06-04
N210875-001	9044475	2030-06-11		Drug product	2020-06-04
N210875-001	9283219	2030-06-11	U-2825	Drug product	2020-06-04
N210875-001	9326981	2030-06-11	U-2825		2020-06-04
N210875-001	9669019	2030-06-11	U-2825	Drug product	2020-06-04
N210875-001	9669021	2030-06-11	U-2825		2020-06-04
N210875-001	11419769	2031-12-16	U-2825	Drug product	2022-09-06
N210875-001	8414922	2031-12-16	U-2825	Drug product	2020-06-04
N210875-001	8846074	2031-12-16	U-2825	Drug product	2020-06-04
N210875-001	10449146	2036-04-19	U-2825		2020-06-04
N210875-001	10959943	2036-04-19	U-2825		2021-04-02
N210875-002	10821074	2029-08-07		Drug product	2020-11-12
N210875-002	10420763	2030-06-11	U-2825	Drug product	2020-06-04
N210875-002	9044475	2030-06-11		Drug product	2020-06-04
N210875-002	9283219	2030-06-11	U-2825	Drug product	2020-06-04
N210875-002	9326981	2030-06-11	U-2825		2020-06-04
N210875-002	9669019	2030-06-11	U-2825	Drug product	2020-06-04
N210875-002	9669021	2030-06-11	U-2825		2020-06-04
N210875-002	11419769	2031-12-16	U-2825	Drug product	2022-09-06
N210875-002	8414922	2031-12-16	U-2825	Drug product	2020-06-04
N210875-002	8846074	2031-12-16	U-2825	Drug product	2020-06-04
N210875-002	10449146	2036-04-19	U-2825		2020-06-04
N210875-002	10959943	2036-04-19	U-2825		2021-04-02
N210875-003	10821074	2029-08-07		Drug product	2020-11-12
N210875-003	10420763	2030-06-11	U-2825	Drug product	2020-06-04
N210875-003	9044475	2030-06-11		Drug product	2020-06-04
N210875-003	9283219	2030-06-11	U-2825	Drug product	2020-06-04
N210875-003	9326981	2030-06-11	U-2825		2020-06-04
N210875-003	9669019	2030-06-11	U-2825	Drug product	2020-06-04
N210875-003	9669021	2030-06-11	U-2825		2020-06-04
N210875-003	11419769	2031-12-16	U-2825	Drug product	2022-09-06
N210875-003	8414922	2031-12-16	U-2825	Drug product	2020-06-04
N210875-003	8846074	2031-12-16	U-2825	Drug product	2020-06-04
N210875-003	10449146	2036-04-19	U-2825		2020-06-04
N210875-003	10959943	2036-04-19	U-2825		2021-04-02
N210875-004	10821074	2029-08-07		Drug product	2020-11-12
N210875-004	10420763	2030-06-11	U-2825	Drug product	2020-06-04
N210875-004	9044475	2030-06-11		Drug product	2020-06-04
N210875-004	9283219	2030-06-11	U-2825	Drug product	2020-06-04
N210875-004	9326981	2030-06-11	U-2825		2020-06-04
N210875-004	9669019	2030-06-11	U-2825	Drug product	2020-06-04
N210875-004	9669021	2030-06-11	U-2825		2020-06-04
N210875-004	11419769	2031-12-16	U-2825	Drug product	2022-09-06
N210875-004	8414922	2031-12-16	U-2825	Drug product	2020-06-04
N210875-004	8846074	2031-12-16	U-2825	Drug product	2020-06-04
N210875-004	10449146	2036-04-19	U-2825		2020-06-04
N210875-004	10959943	2036-04-19	U-2825		2021-04-02
N210875-005	10821074	2029-08-07		Drug product	2020-11-12
N210875-005	10420763	2030-06-11	U-2825	Drug product	2020-06-04
N210875-005	9044475	2030-06-11		Drug product	2020-06-04
N210875-005	9283219	2030-06-11	U-2825	Drug product	2020-06-04
N210875-005	9326981	2030-06-11	U-2825		2020-06-04
N210875-005	9669019	2030-06-11	U-2825	Drug product	2020-06-04
N210875-005	9669021	2030-06-11	U-2825		2020-06-04
N210875-005	11419769	2031-12-16	U-2825	Drug product	2022-09-06
N210875-005	8414922	2031-12-16	U-2825	Drug product	2020-06-04
N210875-005	8846074	2031-12-16	U-2825	Drug product	2020-06-04
N210875-005	10449146	2036-04-19	U-2825		2020-06-04
N210875-005	10959943	2036-04-19	U-2825		2021-04-02

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 5 · 185 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N210875-001	KYNMOBI	10MG	FILM / SUBLINGUAL	RLD	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	KYNMOBI	15MG	FILM / SUBLINGUAL	RLD	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	KYNMOBI	20MG	FILM / SUBLINGUAL	RLD	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-004	KYNMOBI	25MG	FILM / SUBLINGUAL	RLD	2020-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-005	KYNMOBI	30MG	FILM / SUBLINGUAL	RLD	2020-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210875-001	KYNMOBI	10MG	FILM / SUBLINGUAL	RLD	2020-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210875-002	KYNMOBI	15MG	FILM / SUBLINGUAL	RLD	2020-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210875-003	KYNMOBI	20MG	FILM / SUBLINGUAL	RLD	2020-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210875-004	KYNMOBI	25MG	FILM / SUBLINGUAL	RLD	2020-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N210875-005	KYNMOBI	30MG	FILM / SUBLINGUAL	RLD	2020-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N210875-001	KYNMOBI	10MG	FILM / SUBLINGUAL	RLD	2020-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210875-002	KYNMOBI	15MG	FILM / SUBLINGUAL	RLD	2020-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210875-003	KYNMOBI	20MG	FILM / SUBLINGUAL	RLD	2020-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210875-004	KYNMOBI	25MG	FILM / SUBLINGUAL	RLD	2020-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N210875-005	KYNMOBI	30MG	FILM / SUBLINGUAL	RLD	2020-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210875-001	KYNMOBI	10MG	FILM / SUBLINGUAL	RLD	2020-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210875-002	KYNMOBI	15MG	FILM / SUBLINGUAL	RLD	2020-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210875-003	KYNMOBI	20MG	FILM / SUBLINGUAL	RLD	2020-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210875-004	KYNMOBI	25MG	FILM / SUBLINGUAL	RLD	2020-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N210875-005	KYNMOBI	30MG	FILM / SUBLINGUAL	RLD	2020-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210875-001	KYNMOBI	10MG	FILM / SUBLINGUAL	RLD	2020-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210875-002	KYNMOBI	15MG	FILM / SUBLINGUAL	RLD	2020-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210875-003	KYNMOBI	20MG	FILM / SUBLINGUAL	RLD	2020-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210875-004	KYNMOBI	25MG	FILM / SUBLINGUAL	RLD	2020-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N210875-005	KYNMOBI	30MG	FILM / SUBLINGUAL	RLD	2020-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210875-001	KYNMOBI	10MG	FILM / SUBLINGUAL	RLD	2020-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210875-002	KYNMOBI	15MG	FILM / SUBLINGUAL	RLD	2020-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210875-003	KYNMOBI	20MG	FILM / SUBLINGUAL	RLD	2020-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210875-004	KYNMOBI	25MG	FILM / SUBLINGUAL	RLD	2020-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N210875-005	KYNMOBI	30MG	FILM / SUBLINGUAL	RLD	2020-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210875-001	KYNMOBI	10MG	FILM / SUBLINGUAL	RLD	2020-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210875-002	KYNMOBI	15MG	FILM / SUBLINGUAL	RLD	2020-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210875-003	KYNMOBI	20MG	FILM / SUBLINGUAL	RLD	2020-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210875-004	KYNMOBI	25MG	FILM / SUBLINGUAL	RLD	2020-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N210875-005	KYNMOBI	30MG	FILM / SUBLINGUAL	RLD	2020-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210875-001	KYNMOBI	10MG	FILM / SUBLINGUAL	RLD	2020-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210875-002	KYNMOBI	15MG	FILM / SUBLINGUAL	RLD	2020-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210875-003	KYNMOBI	20MG	FILM / SUBLINGUAL	RLD	2020-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210875-004	KYNMOBI	25MG	FILM / SUBLINGUAL	RLD	2020-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N210875-005	KYNMOBI	30MG	FILM / SUBLINGUAL	RLD	2020-05-21	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 71 · 2,810 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	N210875-001	10821074	2029-08-07		Drug product	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	10420763	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	9044475	2030-06-11		Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	9283219	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	9326981	2030-06-11	U-2825		2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	9669019	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	9669021	2030-06-11	U-2825		2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	11419769	2031-12-16	U-2825	Drug product	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	8414922	2031-12-16	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	8846074	2031-12-16	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	10449146	2036-04-19	U-2825		2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-001	10959943	2036-04-19	U-2825		2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	10821074	2029-08-07		Drug product	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	10420763	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	9044475	2030-06-11		Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	9283219	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	9326981	2030-06-11	U-2825		2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	9669019	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	9669021	2030-06-11	U-2825		2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	11419769	2031-12-16	U-2825	Drug product	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	8414922	2031-12-16	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	8846074	2031-12-16	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	10449146	2036-04-19	U-2825		2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-002	10959943	2036-04-19	U-2825		2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	10821074	2029-08-07		Drug product	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	10420763	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	9044475	2030-06-11		Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	9283219	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	9326981	2030-06-11	U-2825		2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	9669019	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	9669021	2030-06-11	U-2825		2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	11419769	2031-12-16	U-2825	Drug product	2022-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	8414922	2031-12-16	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	8846074	2031-12-16	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	10449146	2036-04-19	U-2825		2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-003	10959943	2036-04-19	U-2825		2021-04-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-004	10821074	2029-08-07		Drug product	2020-11-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-004	10420763	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-004	9044475	2030-06-11		Drug product	2020-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N210875-004	9283219	2030-06-11	U-2825	Drug product	2020-06-04	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 100 observed states.

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	N210875-001	NP	2023-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210875-002	NP	2023-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210875-003	NP	2023-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210875-004	NP	2023-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N210875-005	NP	2023-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N210875-001	NP	2023-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210875-002	NP	2023-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210875-003	NP	2023-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210875-004	NP	2023-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N210875-005	NP	2023-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N210875-001	NP	2023-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210875-002	NP	2023-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210875-003	NP	2023-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210875-004	NP	2023-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N210875-005	NP	2023-05-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N210875-001	NP	2023-05-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210875-002	NP	2023-05-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210875-003	NP	2023-05-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210875-004	NP	2023-05-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N210875-005	NP	2023-05-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N210875-001	NP	2023-05-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210875-002	NP	2023-05-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210875-003	NP	2023-05-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210875-004	NP	2023-05-21	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N210875-005	NP	2023-05-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210875-001	NP	2023-05-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210875-002	NP	2023-05-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210875-003	NP	2023-05-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210875-004	NP	2023-05-21	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N210875-005	NP	2023-05-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N210875-001	NP	2023-05-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210875-002	NP	2023-05-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210875-003	NP	2023-05-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210875-004	NP	2023-05-21	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N210875-005	NP	2023-05-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N210875-001	NP	2023-05-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210875-002	NP	2023-05-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210875-003	NP	2023-05-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210875-004	NP	2023-05-21	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N210875-005	NP	2023-05-21	`8869cabd3fbd…`

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
ONAPGO	APOMORPHINE HYDROCHLORIDE	MDD US Operations, LLC, a subsidiary of Supernus Pharmaceuticals, Inc	f3552b6e-5ae7-4993-aa1a-e399c4a7080a	2026-07-10	Warnings, Adverse reactions	Name fallback generic name: APOMORPHINE HYDROCHLORIDE
apomorphine hydrocloride	APOMORPHINE HYDROCHLORIDE	TruPharma, LLC	aedf70e4-1949-44bc-bf1b-0f282c4f0705	2022-02-24	Warnings, Adverse reactions	Name fallback generic name: APOMORPHINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 72 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63402-010	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-010	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-010	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-010	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-010	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-010	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-015	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-015	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-015	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-015	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-015	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-015	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-020	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-020	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-020	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-020	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-020	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-020	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-025	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-025	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-025	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-025	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-025	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-025	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-030	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-030	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-030	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-030	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-030	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-030	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-088	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-088	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-088	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-088	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-088	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-088	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-110	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-110	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-110	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-110	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-110	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-110	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-115	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-115	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-115	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-115	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-115	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-115	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-120	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-120	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-120	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-120	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-120	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-120	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-125	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-125	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-125	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-125	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-125	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-125	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-130	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-130	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-130	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-130	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-130	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-130	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-188	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-188	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-188	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-188	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-188	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current
63402-188	KYNMOBI	apomorphine hydrochloride	Sunovion Pharmaceuticals Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72149	SUPPL	2022-09-23
72144	SUPPL	2022-09-23
71022	SUPPL	2022-05-06
71007	SUPPL	2022-05-06
64831	ORIG	2020-10-06
63317	ORIG	2020-05-28
63250	ORIG	2020-05-21