Application 209819

Type: NDA
Sponsor: INDIVIOR INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUBLOCADE	BUPRENORPHINE	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	100MG/0.5ML (100MG/0.5ML)	Yes	No
002	SUBLOCADE	BUPRENORPHINE	SOLUTION, EXTENDED RELEASE;SUBCUTANEOUS	300MG/1.5ML (200MG/ML)	Yes	Yes

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

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
N209819-001	SUBLOCADE	BUPRENORPHINE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS		RLD	2017-11-30
N209819-002	SUBLOCADE	BUPRENORPHINE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS		RLD, RS	2017-11-30

Orange Book patents#

Current patent rows page 1 of 1 · 49 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209819-001	10198218	2031-06-06	U-2489		2019-02-15
N209819-001	10592168	2031-06-06	U-2489		2020-03-19
N209819-001	9272044	2031-06-06	U-2176		2017-12-13
N209819-001	9272044	2031-06-06	U-2177		2017-12-13
N209819-001	9272044	2031-06-06	U-2178		2017-12-13
N209819-001	9272044	2031-06-06	U-2209		2017-12-13
N209819-001	9498432	2031-06-06	U-2179	Drug product	2017-12-13
N209819-001	9782402	2031-06-06	U-2176	Drug product	2017-12-13
N209819-001	9782402	2031-06-06	U-2180	Drug product	2017-12-13
N209819-001	9782402	2031-06-06	U-2207	Drug product	2017-12-13
N209819-001	9782402	2031-06-06	U-2208	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2174	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2181	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2206	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2210	Drug product	2017-12-13
N209819-001	9827241	2031-06-06	U-2211	Drug product	2017-12-13
N209819-001	10558394	2031-06-25		Drug product	2020-02-18
N209819-001	8975270	2031-09-05	U-2175	Drug product	2017-12-13
N209819-001	8975270	2031-09-05	U-2206	Drug product	2017-12-13
N209819-001	8921387	2032-01-06	U-2173	Drug product	2017-12-13
N209819-001	8921387	2032-01-06	U-2174	Drug product	2017-12-13
N209819-001	11000520	2035-11-06	U-3111		2021-05-20
N209819-001	11839611	2035-11-06	U-3111		2024-01-08
N209819-001	12622904	2035-11-06	U-4528		2026-06-05
N209819-002	10198218	2031-06-06	U-2489		2019-02-15
N209819-002	10592168	2031-06-06	U-2489		2020-03-19
N209819-002	9272044	2031-06-06	U-2176		2017-12-13
N209819-002	9272044	2031-06-06	U-2177		2017-12-13
N209819-002	9272044	2031-06-06	U-2178		2017-12-13
N209819-002	9272044	2031-06-06	U-2209		2017-12-13
N209819-002	9498432	2031-06-06	U-2179	Drug product	2017-12-13
N209819-002	9782402	2031-06-06	U-2176	Drug product	2017-12-13
N209819-002	9782402	2031-06-06	U-2180	Drug product	2017-12-13
N209819-002	9782402	2031-06-06	U-2207	Drug product	2017-12-13
N209819-002	9782402	2031-06-06	U-2208	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2174	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2181	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2206	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2210	Drug product	2017-12-13
N209819-002	9827241	2031-06-06	U-2211	Drug product	2017-12-13
N209819-002	10558394	2031-06-25		Drug product	2020-07-16
N209819-002	8975270	2031-09-05	U-2175	Drug product	2017-12-13
N209819-002	8975270	2031-09-05	U-2206	Drug product	2017-12-13
N209819-002	8921387	2032-01-06	U-2173	Drug product	2017-12-13
N209819-002	8921387	2032-01-06	U-2174	Drug product	2017-12-13
N209819-002	11000520	2035-11-06	U-3111		2021-05-20
N209819-002	11839611	2035-11-06	U-3111		2024-01-08
N209819-002	12622904	2035-11-06	U-4528		2026-06-05
N209819-002	10646484	2038-06-22	U-2489		2020-05-12

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N209819-001	M-314	2028-02-21
N209819-002	M-314	2028-02-21

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 3 · 82 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	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N209819-001	SUBLOCADE	100MG/0.5ML (100MG/0.5ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD	2017-11-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N209819-002	SUBLOCADE	300MG/1.5ML (200MG/ML)	SOLUTION, EXTENDED RELEASE / SUBCUTANEOUS	RLD, RS	2017-11-30	`782e0a99824c…`

Observed Orange Book patent history#

Patent history page 1 of 47 · 1,845 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	N209819-001	10198218	2031-06-06	U-2489		2019-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	10592168	2031-06-06	U-2489		2020-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9272044	2031-06-06	U-2176		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9272044	2031-06-06	U-2209		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9272044	2031-06-06	U-2178		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9272044	2031-06-06	U-2177		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9498432	2031-06-06	U-2179	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9782402	2031-06-06	U-2180	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9782402	2031-06-06	U-2176	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9782402	2031-06-06	U-2208	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9782402	2031-06-06	U-2207	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2206	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2211	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2181	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2210	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	9827241	2031-06-06	U-2174	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	10558394	2031-06-25		Drug product	2020-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	8975270	2031-09-05	U-2206	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	8975270	2031-09-05	U-2175	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	8921387	2032-01-06	U-2174	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	8921387	2032-01-06	U-2173	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	11000520	2035-11-06	U-3111		2021-05-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-001	11839611	2035-11-06	U-3111		2024-01-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	10198218	2031-06-06	U-2489		2019-02-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	10592168	2031-06-06	U-2489		2020-03-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9272044	2031-06-06	U-2209		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9272044	2031-06-06	U-2178		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9272044	2031-06-06	U-2176		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9272044	2031-06-06	U-2177		2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9498432	2031-06-06	U-2179	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9782402	2031-06-06	U-2208	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9782402	2031-06-06	U-2207	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9782402	2031-06-06	U-2180	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9782402	2031-06-06	U-2176	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2181	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2206	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2211	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2174	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	9827241	2031-06-06	U-2210	Drug product	2017-12-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	10558394	2031-06-25		Drug product	2020-07-16	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N209819-001	M-314	2028-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209819-002	M-314	2028-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209819-001	M-314	2028-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209819-002	M-314	2028-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N209819-001	M-314	2028-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N209819-002	M-314	2028-02-21	`6a471c1ec25d…`
2019-12-13 00:20 UTC	2019-12	N209819-001	NP	2020-11-30	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N209819-002	NP	2020-11-30	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N209819-001	NP	2020-11-30	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N209819-002	NP	2020-11-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209819-001	NP	2020-11-30	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N209819-002	NP	2020-11-30	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209819-001	NP	2020-11-30	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N209819-002	NP	2020-11-30	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209819-001	NP	2020-11-30	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N209819-002	NP	2020-11-30	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209819-001	NP	2020-11-30	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N209819-002	NP	2020-11-30	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209819-001	M-314	2028-02-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209819-002	M-314	2028-02-21	`a50c72e98297…`

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
SUBLOCADE	BUPRENORPHINE	Indivior Inc.	6189fb21-9432-45f8-8481-0bfaf3ccde95	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209819 application number: NDA209819 ndc (product): 12496-0100 ndc (product): 12496-0300

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0100	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current
12496-0300	SUBLOCADE	buprenorphine	Indivior Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84656	SUPPL	2026-01-06
84584	SUPPL	2025-12-29
83608	SUPPL	2025-09-30
81338	SUPPL	2025-09-30
81942	SUPPL	2025-04-21
81339	SUPPL	2025-02-24
78192	SUPPL	2024-04-22
77059	SUPPL	2023-12-19
76968	SUPPL	2023-12-18
76280	ORIG	2023-11-03
75658	SUPPL	2023-10-03
75650	SUPPL	2023-10-03
74688	SUPPL	2023-07-05
73756	SUPPL	2023-03-14
73743	SUPPL	2023-03-14
73122	SUPPL	2023-01-09
71894	SUPPL	2022-08-25
71875	SUPPL	2022-08-24
71411	SUPPL	2022-06-21
71382	SUPPL	2022-06-21
68799	SUPPL	2021-09-28
67878	SUPPL	2021-06-23
67877	SUPPL	2021-06-23
67868	SUPPL	2021-06-23
67469	SUPPL	2021-05-12
67456	SUPPL	2021-05-12
66541	SUPPL	2021-03-08
66532	SUPPL	2021-03-08
66536	SUPPL	2021-03-05
66535	SUPPL	2021-03-05
66534	SUPPL	2021-03-05
66533	SUPPL	2021-03-05
63585	SUPPL	2020-06-17
61997	SUPPL	2020-02-28
61996	SUPPL	2020-02-28
61780	SUPPL	2020-02-05
60318	SUPPL	2019-10-08
60290	SUPPL	2019-10-08
55867	ORIG	2018-10-11
53069	ORIG	2018-03-21
52999	SUPPL	2018-03-15
52851	SUPPL	2018-03-08
50576	ORIG	2017-12-01
50537	ORIG	2017-12-01