Application 207533

Type: NDA
Sponsor: ALKERMES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARISTADA	ARIPIPRAZOLE LAUROXIL	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	441MG/1.6ML (275.63MG/ML)	Yes	No
002	ARISTADA	ARIPIPRAZOLE LAUROXIL	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	662MG/2.4ML (275.83MG/ML)	Yes	No
003	ARISTADA	ARIPIPRAZOLE LAUROXIL	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	882MG/3.2ML (275.63MG/ML)	Yes	Yes
004	ARISTADA	ARIPIPRAZOLE LAUROXIL	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	1064MG/3.9ML (272.82MG/ML)	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N207533-001	ARISTADA	ARIPIPRAZOLE LAUROXIL	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05
N207533-002	ARISTADA	ARIPIPRAZOLE LAUROXIL	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05
N207533-003	ARISTADA	ARIPIPRAZOLE LAUROXIL	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05
N207533-004	ARISTADA	ARIPIPRAZOLE LAUROXIL	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05

Orange Book patents#

Current patent rows page 1 of 1 · 70 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N207533-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N207533-001	8796276	2030-06-24	U-543		2015-10-14
N207533-001	8431576	2030-10-26		Drug substance	2015-10-14
N207533-001	10226458	2032-03-19	U-543		2019-04-08
N207533-001	9034867	2032-11-07	U-543	Drug product	2015-10-14
N207533-001	12629366	2032-12-06	U-764	Drug product	2026-06-18
N207533-001	11097006	2033-09-19	U-764	Drug product	2021-10-21
N207533-001	12311027	2033-09-19	U-543	Drug product	2025-07-17
N207533-001	9193685	2033-10-24	U-543	Drug product	2015-12-09
N207533-001	11969469	2034-04-06		Drug product	2024-05-16
N207533-001	10238651	2035-03-19	U-2402		2019-04-08
N207533-001	10813928	2035-03-19	U-2983		2020-11-10
N207533-001	11406632	2035-03-19	U-2402		2022-08-19
N207533-001	12653822	2035-03-19	U-2402		2026-07-15
N207533-001	9452131	2035-03-19	U-2402		2016-10-05
N207533-001	11273158	2039-04-06	U-543		2022-04-13
N207533-001	12251381	2039-04-06	U-543		2025-04-08
N207533-002	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N207533-002	8796276	2030-06-24	U-543		2015-10-14
N207533-002	8431576	2030-10-26		Drug substance	2015-10-14
N207533-002	10226458	2032-03-19	U-543		2019-04-08
N207533-002	9034867	2032-11-07	U-543	Drug product	2015-10-14
N207533-002	12629366	2032-12-06	U-764	Drug product	2026-06-18
N207533-002	11097006	2033-09-19	U-764	Drug product	2021-10-21
N207533-002	12311027	2033-09-19	U-543	Drug product	2025-07-17
N207533-002	9193685	2033-10-24	U-543	Drug product	2015-12-09
N207533-002	11969469	2034-04-06		Drug product	2024-05-16
N207533-002	10238651	2035-03-19	U-2402		2019-04-08
N207533-002	10813928	2035-03-19	U-2983		2020-11-10
N207533-002	11406632	2035-03-19	U-2402		2022-08-19
N207533-002	12653822	2035-03-19	U-2402		2026-07-15
N207533-002	9452131	2035-03-19	U-2402		2016-10-05
N207533-002	9526726	2035-03-19		Drug product	2017-01-19
N207533-002	11273158	2039-04-06	U-543		2022-04-13
N207533-002	12251381	2039-04-06	U-543		2025-04-08
N207533-003	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N207533-003	8796276	2030-06-24	U-543		2015-10-14
N207533-003	8431576	2030-10-26		Drug substance	2015-10-14
N207533-003	10226458	2032-03-19	U-543		2019-04-08
N207533-003	9034867	2032-11-07	U-543	Drug product	2015-10-14
N207533-003	12629366	2032-12-06	U-764	Drug product	2026-06-18
N207533-003	11097006	2033-09-19	U-764	Drug product	2021-10-21
N207533-003	12311027	2033-09-19	U-543	Drug product	2025-07-17
N207533-003	9193685	2033-10-24	U-543	Drug product	2015-12-09
N207533-003	11969469	2034-04-06		Drug product	2024-05-16
N207533-003	10238651	2035-03-19	U-2402		2019-04-08
N207533-003	10813928	2035-03-19	U-2402		2020-11-10
N207533-003	11406632	2035-03-19	U-2402		2022-08-19
N207533-003	12653822	2035-03-19	U-2402		2026-07-15
N207533-003	9452131	2035-03-19	U-2402		2016-10-05
N207533-003	9526726	2035-03-19		Drug product	2017-01-19
N207533-003	11273158	2039-04-06	U-543		2022-04-13
N207533-003	12251381	2039-04-06	U-543		2025-04-08
N207533-004	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N207533-004	8796276	2030-06-24	U-543		2017-06-27
N207533-004	8431576	2030-10-26		Drug substance	2017-06-27
N207533-004	10226458	2032-03-19	U-543		2019-04-08
N207533-004	9034867	2032-11-07	U-543	Drug product	2017-06-27
N207533-004	12629366	2032-12-06	U-764	Drug product	2026-06-18
N207533-004	11097006	2033-09-19	U-764	Drug product	2021-10-21
N207533-004	12311027	2033-09-19	U-543	Drug product	2025-07-17
N207533-004	9193685	2033-10-24	U-543	Drug product	2017-06-27
N207533-004	11969469	2034-04-06		Drug product	2024-05-16
N207533-004	10238651	2035-03-19	U-2402		2019-04-08
N207533-004	10813928	2035-03-19	U-2983		2020-11-10
N207533-004	11406632	2035-03-19	U-2402		2022-08-19
N207533-004	12653822	2035-03-19	U-2402		2026-07-15
N207533-004	9452131	2035-03-19	U-2402		2017-06-27
N207533-004	11273158	2039-04-06	U-543		2022-04-13
N207533-004	12251381	2039-04-06	U-543		2025-04-08

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 · 168 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207533-001	ARISTADA	441MG/1.6ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207533-002	ARISTADA	662MG/2.4ML (275.83MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2015-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207533-003	ARISTADA	882MG/3.2ML (275.63MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2015-10-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N207533-004	ARISTADA	1064MG/3.9ML (272.82MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2017-06-05	`d8e5a09893c0…`

Observed Orange Book patent history#

Patent history page 1 of 51 · 2,016 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N207533-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	8796276	2030-06-24	U-543		2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	8431576	2030-10-26		Drug substance	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	10226458	2032-03-19	U-543		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	9034867	2032-11-07	U-543	Drug product	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	12629366	2032-12-06	U-764	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	11097006	2033-09-19	U-764	Drug product	2021-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	12311027	2033-09-19	U-543	Drug product	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	9193685	2033-10-24	U-543	Drug product	2015-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	11969469	2034-04-06		Drug product	2024-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	10238651	2035-03-19	U-2402		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	10813928	2035-03-19	U-2983		2020-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	11406632	2035-03-19	U-2402		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	12653822	2035-03-19	U-2402		2026-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	9452131	2035-03-19	U-2402		2016-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	11273158	2039-04-06	U-543		2022-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-001	12251381	2039-04-06	U-543		2025-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	8796276	2030-06-24	U-543		2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	8431576	2030-10-26		Drug substance	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	10226458	2032-03-19	U-543		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	9034867	2032-11-07	U-543	Drug product	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	12629366	2032-12-06	U-764	Drug product	2026-06-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	11097006	2033-09-19	U-764	Drug product	2021-10-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	12311027	2033-09-19	U-543	Drug product	2025-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	9193685	2033-10-24	U-543	Drug product	2015-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	11969469	2034-04-06		Drug product	2024-05-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	10238651	2035-03-19	U-2402		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	10813928	2035-03-19	U-2983		2020-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	11406632	2035-03-19	U-2402		2022-08-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	12653822	2035-03-19	U-2402		2026-07-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	9452131	2035-03-19	U-2402		2016-10-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	9526726	2035-03-19		Drug product	2017-01-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	11273158	2039-04-06	U-543		2022-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-002	12251381	2039-04-06	U-543		2025-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	8796276	2030-06-24	U-543		2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	8431576	2030-10-26		Drug substance	2015-10-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	10226458	2032-03-19	U-543		2019-04-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N207533-003	9034867	2032-11-07	U-543	Drug product	2015-10-14	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N207533-001	NCE	2020-10-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207533-002	NCE	2020-10-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207533-003	NCE	2020-10-05	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N207533-004	NCE	2020-10-05	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N207533-001	NCE	2020-10-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207533-002	NCE	2020-10-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207533-003	NCE	2020-10-05	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N207533-004	NCE	2020-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N207533-001	NCE	2020-10-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207533-002	NCE	2020-10-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207533-003	NCE	2020-10-05	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N207533-004	NCE	2020-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N207533-001	NCE	2020-10-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207533-002	NCE	2020-10-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207533-003	NCE	2020-10-05	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N207533-004	NCE	2020-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N207533-001	NCE	2020-10-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207533-002	NCE	2020-10-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207533-003	NCE	2020-10-05	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N207533-004	NCE	2020-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N207533-001	NCE	2020-10-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207533-002	NCE	2020-10-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207533-003	NCE	2020-10-05	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N207533-004	NCE	2020-10-05	`ea99ee380514…`

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
ARISTADA	ARIPIPRAZOLE LAUROXIL	Alkermes, Inc.	17a8d11b-73b0-4833-a0b4-cf1ef85edefb	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 207533 application number: NDA207533 ndc (product): 65757-404 ndc (product): 65757-401 ndc (product): 65757-403 ndc (product): 65757-402

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65757-401	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-401	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-401	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-401	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-401	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-401	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-401	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-401	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-402	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-402	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-402	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-402	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-402	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-402	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-402	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-402	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-403	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-403	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-403	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-403	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-403	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-403	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-403	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-403	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-404	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-404	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-404	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-404	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-404	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-404	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-404	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-404	ARISTADA	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81150	SUPPL	2025-02-07
80952	SUPPL	2025-02-05
80951	SUPPL	2025-02-05
66932	SUPPL	2021-03-31
64504	SUPPL	2020-09-04
64503	SUPPL	2020-09-04
64442	SUPPL	2020-08-28
56616	SUPPL	2018-12-03
52123	SUPPL	2018-01-30
48666	SUPPL	2017-06-07
48660	SUPPL	2017-06-06
48659	SUPPL	2017-06-06
47406	SUPPL	2017-03-02
47322	SUPPL	2017-02-24
45097	SUPPL	2016-08-22
45143	SUPPL	2016-08-18
23036	ORIG	2015-10-28
24526	ORIG	2015-10-16
19963	ORIG	2015-10-13
10619	ORIG	2015-10-13