Application 212994

Type: NDA
Sponsor: COMMCAVE THERAPEUTICS SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	AZSTARYS	SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE	CAPSULE;ORAL	26.1MG/5.2MG	Yes	No
002	AZSTARYS	SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE	CAPSULE;ORAL	39.2MG/7.8MG	Yes	No
003	AZSTARYS	SERDEXMETHYLPHENIDATE;DEXMETHYLPHENIDATE	CAPSULE;ORAL	52.3MG/10.4MG	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N212994-001	AZSTARYS	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07
N212994-002	AZSTARYS	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07
N212994-003	AZSTARYS	DEXMETHYLPHENIDATE HYDROCHLORIDE; SERDEXMETHYLPHENIDATE CHLORIDE	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07

Orange Book patents#

Current patent rows page 1 of 1 · 18 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212994-001	9079928	2035-05-07		Drug product	2021-05-17
N212994-001	10584112	2037-12-09		Drug substance, Drug product	2021-05-17
N212994-001	10584113	2037-12-09		Drug product	2021-05-17
N212994-001	10759778	2037-12-09		Drug product	2021-05-17
N212994-001	10858341	2037-12-09	U-3094		2021-05-17
N212994-001	10954213	2037-12-09	U-3094		2021-05-17
N212994-002	9079928	2035-05-07		Drug product	2021-05-17
N212994-002	10584112	2037-12-09		Drug substance, Drug product	2021-05-17
N212994-002	10584113	2037-12-09		Drug product	2021-05-17
N212994-002	10759778	2037-12-09		Drug product	2021-05-17
N212994-002	10858341	2037-12-09	U-3094		2021-05-17
N212994-002	10954213	2037-12-09	U-3094		2021-05-17
N212994-003	9079928	2035-05-07		Drug product	2021-05-17
N212994-003	10584112	2037-12-09		Drug substance, Drug product	2021-05-17
N212994-003	10584113	2037-12-09		Drug product	2021-05-17
N212994-003	10759778	2037-12-09		Drug product	2021-05-17
N212994-003	10858341	2037-12-09	U-3094		2021-05-17
N212994-003	10954213	2037-12-09	U-3094		2021-05-17

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N212994-001	NCE	2026-05-07
N212994-002	NCE	2026-05-07
N212994-003	NCE	2026-05-07

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 · 105 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	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-002	AZSTARYS	EQ 7.8MG BASE;EQ 39.2MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-003	AZSTARYS	EQ 10.4MG BASE;EQ 52.3MG BASE	CAPSULE / ORAL	RLD, RS	2021-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212994-001	AZSTARYS	EQ 5.2MG BASE;EQ 26.1MG BASE	CAPSULE / ORAL	RLD	2021-05-07	`301d65b070ca…`

Observed Orange Book patent history#

Patent history page 1 of 16 · 630 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	N212994-001	9079928	2035-05-07		Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-001	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-001	10584113	2037-12-09		Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-001	10759778	2037-12-09		Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-001	10858341	2037-12-09	U-3094		2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-001	10954213	2037-12-09	U-3094		2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-002	9079928	2035-05-07		Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-002	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-002	10584113	2037-12-09		Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-002	10759778	2037-12-09		Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-002	10858341	2037-12-09	U-3094		2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-002	10954213	2037-12-09	U-3094		2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-003	9079928	2035-05-07		Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-003	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-003	10584113	2037-12-09		Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-003	10759778	2037-12-09		Drug product	2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-003	10858341	2037-12-09	U-3094		2021-05-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-003	10954213	2037-12-09	U-3094		2021-05-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212994-001	9079928	2035-05-07		Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-001	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-001	10584113	2037-12-09		Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-001	10759778	2037-12-09		Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-001	10858341	2037-12-09	U-3094		2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-001	10954213	2037-12-09	U-3094		2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-002	9079928	2035-05-07		Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-002	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-002	10584113	2037-12-09		Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-002	10759778	2037-12-09		Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-002	10858341	2037-12-09	U-3094		2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-002	10954213	2037-12-09	U-3094		2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-003	9079928	2035-05-07		Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-003	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-003	10584113	2037-12-09		Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-003	10759778	2037-12-09		Drug product	2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-003	10858341	2037-12-09	U-3094		2021-05-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-003	10954213	2037-12-09	U-3094		2021-05-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212994-001	9079928	2032-07-27		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-001	10584112	2037-12-09		Drug substance, Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-001	10584113	2037-12-09		Drug product	2021-05-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-001	10759778	2037-12-09		Drug product	2021-05-17	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 3 · 105 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N212994-001	NCE	2026-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-002	NCE	2026-05-07	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N212994-003	NCE	2026-05-07	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N212994-001	NCE	2026-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-002	NCE	2026-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212994-003	NCE	2026-05-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212994-001	NCE	2026-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-002	NCE	2026-05-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212994-003	NCE	2026-05-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-001	NCE	2026-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-002	NCE	2026-05-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212994-003	NCE	2026-05-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212994-001	NCE	2026-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-002	NCE	2026-05-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212994-003	NCE	2026-05-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-001	NCE	2026-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-002	NCE	2026-05-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212994-003	NCE	2026-05-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-001	NCE	2026-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-002	NCE	2026-05-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212994-003	NCE	2026-05-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-001	NCE	2026-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-002	NCE	2026-05-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212994-003	NCE	2026-05-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-001	NCE	2026-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-002	NCE	2026-05-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212994-003	NCE	2026-05-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-001	NCE	2026-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-002	NCE	2026-05-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N212994-003	NCE	2026-05-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-001	NCE	2026-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-002	NCE	2026-05-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N212994-003	NCE	2026-05-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N212994-001	NCE	2026-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212994-002	NCE	2026-05-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N212994-003	NCE	2026-05-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-001	NCE	2026-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-002	NCE	2026-05-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N212994-003	NCE	2026-05-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N212994-001	NCE	2026-05-07	`301d65b070ca…`

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
AZSTARYS	SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE	Commave Sub, LLC	00b5e716-5564-4bbd-acaf-df2bc45a5663	2026-05-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 212994 application number: NDA212994 ndc (product): 65038-429 ndc (product): 65038-561 ndc (product): 65038-286

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 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65038-286	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-286	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-286	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-286	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-286	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-429	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-429	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-429	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-429	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-429	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-561	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-561	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-561	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-561	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current
65038-561	AZSTARYS	Serdexmethylphenidate and Dexmethylphenidate	Corium, Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
83506	SUPPL	2025-09-25
83505	SUPPL	2025-09-25
83464	SUPPL	2025-09-25
75890	SUPPL	2023-10-23
75891	SUPPL	2023-10-17
75859	SUPPL	2023-10-17
75827	SUPPL	2023-10-17
68936	ORIG	2021-10-08
66937	ORIG	2021-04-01
66497	ORIG	2021-03-04
66495	ORIG	2021-03-04
66493	ORIG	2021-03-04