Application 209830

Type: NDA
Sponsor: ALKERMES INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ARISTADA INITIO KIT	ARIPIPRAZOLE LAUROXIL	SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	675MG/2.4ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N209830-001	ARISTADA INITIO KIT	ARIPIPRAZOLE LAUROXIL	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2018-06-29

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20
N209830-001	8796276	2030-06-24	U-543		2018-07-18
N209830-001	8431576	2030-10-26		Drug substance	2018-07-18
N209830-001	10688091	2035-08-17		Drug product	2020-07-08
N209830-001	10849894	2035-08-17	U-543		2020-12-09
N209830-001	11154552	2035-08-17		Drug product	2021-11-10
N209830-001	10016415	2035-09-08		Drug product	2018-07-18
N209830-001	11273158	2039-04-06	U-543		2022-04-13
N209830-001	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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2018-06-29	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N209830-001	ARISTADA INITIO KIT	675MG/2.4ML (281.25MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2018-06-29	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 330 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209830-001	10849894	2035-08-17	U-543		2020-12-09	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209830-001	11154552	2035-08-17		Drug product	2021-11-10	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209830-001	10016415	2035-09-08		Drug product	2018-07-18	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209830-001	11273158	2039-04-06	U-543		2022-04-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N209830-001	12251381	2039-04-06	U-543		2025-04-08	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209830-001	10849894	2035-08-17	U-543		2020-12-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209830-001	11154552	2035-08-17		Drug product	2021-11-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209830-001	10016415	2035-09-08		Drug product	2018-07-18	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209830-001	11273158	2039-04-06	U-543		2022-04-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N209830-001	12251381	2039-04-06	U-543		2025-04-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	10849894	2035-08-17	U-543		2020-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	11154552	2035-08-17		Drug product	2021-11-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	10016415	2035-09-08		Drug product	2018-07-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	11273158	2039-04-06	U-543		2022-04-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N209830-001	12251381	2039-04-06	U-543		2025-04-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	10849894	2035-08-17	U-543		2020-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	11154552	2035-08-17		Drug product	2021-11-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	10016415	2035-09-08		Drug product	2018-07-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	11273158	2039-04-06	U-543		2022-04-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N209830-001	12251381	2039-04-06	U-543		2025-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	10112903	2030-06-24	U-543	Drug substance	2018-11-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	8796276	2030-06-24	U-543		2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	8431576	2030-10-26		Drug substance	2018-07-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N209830-001	10688091	2035-08-17		Drug product	2020-07-08	`31067a03dcf5…`

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	N209830-001	NCE	2020-10-05	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	N209830-001	NCE	2020-10-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N209830-001	NCE	2020-10-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N209830-001	NCE	2020-10-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N209830-001	NCE	2020-10-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N209830-001	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 INITIO	ARIPIPRAZOLE LAUROXIL	Alkermes, Inc.	b18fdfd9-31cd-4a2f-9f1c-ebc70d7a9403	2025-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 209830 application number: NDA209830 ndc (product): 65757-500

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current
65757-500	ARISTADA INITIO	aripiprazole lauroxil	Alkermes, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81156	SUPPL	2025-02-07
80950	SUPPL	2025-02-05
80949	SUPPL	2025-02-05
66934	SUPPL	2021-03-31
64510	SUPPL	2020-09-04
64509	SUPPL	2020-09-04
64443	SUPPL	2020-08-28
59054	ORIG	2019-06-13
54821	ORIG	2018-07-06