Application 202810

Type: NDA
Sponsor: SUPERNUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	OXTELLAR XR	OXCARBAZEPINE	TABLET, EXTENDED RELEASE;ORAL	150MG	Yes	No
002	OXTELLAR XR	OXCARBAZEPINE	TABLET, EXTENDED RELEASE;ORAL	300MG	Yes	No
003	OXTELLAR XR	OXCARBAZEPINE	TABLET, EXTENDED RELEASE;ORAL	600MG	Yes	Yes

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

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	TE codes	RLD / RS	Approval date
N202810-001	OXTELLAR XR	OXCARBAZEPINE	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19
N202810-002	OXTELLAR XR	OXCARBAZEPINE	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19
N202810-003	OXTELLAR XR	OXCARBAZEPINE	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
N202810-001	AB
N202810-002	AB
N202810-003	AB

Orange Book patents#

Current patent rows page 1 of 1 · 33 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N202810-001	10220042	2027-04-13	U-2501		2019-03-28
N202810-001	11166960	2027-04-13		Drug product	2021-11-24
N202810-001	11896599	2027-04-13		Drug product	2024-02-28
N202810-001	7722898	2027-04-13		Drug product	2012-11-20
N202810-001	7910131	2027-04-13	U-2041		2012-11-20
N202810-001	8617600	2027-04-13		Drug product
N202810-001	8821930	2027-04-13		Drug product
N202810-001	9119791	2027-04-13	U-2041		2015-09-11
N202810-001	9351975	2027-04-13		Drug product	2016-06-10
N202810-001	9370525	2027-04-13		Drug product	2016-06-24
N202810-001	9855278	2027-04-13		Drug product	2018-01-05
N202810-002	10220042	2027-04-13	U-2501		2019-03-28
N202810-002	11166960	2027-04-13		Drug product	2021-11-24
N202810-002	11896599	2027-04-13		Drug product	2024-02-28
N202810-002	7722898	2027-04-13		Drug product
N202810-002	7910131	2027-04-13	U-2041
N202810-002	8617600	2027-04-13		Drug product
N202810-002	8821930	2027-04-13		Drug product
N202810-002	9119791	2027-04-13	U-2041		2015-09-11
N202810-002	9351975	2027-04-13		Drug product	2016-06-10
N202810-002	9370525	2027-04-13		Drug product	2016-06-24
N202810-002	9855278	2027-04-13		Drug product	2018-01-05
N202810-003	10220042	2027-04-13	U-2501		2019-03-28
N202810-003	11166960	2027-04-13		Drug product	2021-11-24
N202810-003	11896599	2027-04-13		Drug product	2024-02-28
N202810-003	7722898	2027-04-13		Drug product
N202810-003	7910131	2027-04-13	U-2041
N202810-003	8617600	2027-04-13		Drug product
N202810-003	8821930	2027-04-13		Drug product
N202810-003	9119791	2027-04-13	U-2041		2015-09-11
N202810-003	9351975	2027-04-13		Drug product	2016-06-10
N202810-003	9370525	2027-04-13		Drug product	2016-06-24
N202810-003	9855278	2027-04-13		Drug product	2018-01-05

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 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 51 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N202810-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202810-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N202810-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N202810-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202810-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N202810-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N202810-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N202810-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N202810-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N202810-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N202810-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N202810-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N202810-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202810-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N202810-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N202810-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N202810-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N202810-001	AB	1	`1e350fbaab3a…`

Observed Orange Book patent history#

Patent history page 1 of 33 · 1,287 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	N202810-001	10220042	2027-04-13	U-2501		2019-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	11166960	2027-04-13		Drug product	2021-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	11896599	2027-04-13		Drug product	2024-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	7722898	2027-04-13		Drug product	2012-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	7910131	2027-04-13	U-2041		2012-11-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	8617600	2027-04-13		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	8821930	2027-04-13		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	9119791	2027-04-13	U-2041		2015-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	9351975	2027-04-13		Drug product	2016-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	9370525	2027-04-13		Drug product	2016-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-001	9855278	2027-04-13		Drug product	2018-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	10220042	2027-04-13	U-2501		2019-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	11166960	2027-04-13		Drug product	2021-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	11896599	2027-04-13		Drug product	2024-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	7722898	2027-04-13		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	7910131	2027-04-13	U-2041			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	8617600	2027-04-13		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	8821930	2027-04-13		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	9119791	2027-04-13	U-2041		2015-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	9351975	2027-04-13		Drug product	2016-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	9370525	2027-04-13		Drug product	2016-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-002	9855278	2027-04-13		Drug product	2018-01-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	10220042	2027-04-13	U-2501		2019-03-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	11166960	2027-04-13		Drug product	2021-11-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	11896599	2027-04-13		Drug product	2024-02-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	7722898	2027-04-13		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	7910131	2027-04-13	U-2041			`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	8617600	2027-04-13		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	8821930	2027-04-13		Drug product		`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	9119791	2027-04-13	U-2041		2015-09-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	9351975	2027-04-13		Drug product	2016-06-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	9370525	2027-04-13		Drug product	2016-06-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N202810-003	9855278	2027-04-13		Drug product	2018-01-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N202810-001	10220042	2027-04-13	U-2501		2019-03-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	11166960	2027-04-13		Drug product	2021-11-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	11896599	2027-04-13		Drug product	2024-02-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	7722898	2027-04-13		Drug product	2012-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	7910131	2027-04-13	U-2041		2012-11-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	8617600	2027-04-13		Drug product		`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N202810-001	8821930	2027-04-13		Drug product		`011fe1cb6892…`

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
OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	aa610e56-1d1d-11e1-8bc2-0800200c9a66	2025-10-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 202810 application number: NDA202810 ndc (product): 17772-121 ndc (product): 17772-122 ndc (product): 17772-123

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17772-121	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-121	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-121	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-121	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-122	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-122	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-122	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-122	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-123	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-123	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-123	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current
17772-123	OXTELLAR XR	OXCARBAZEPINE	Supernus Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
79416	SUPPL	2024-08-16
79410	SUPPL	2024-08-16
79409	SUPPL	2024-08-16
75289	SUPPL	2023-08-25
75023	SUPPL	2023-08-09
57152	SUPPL	2019-01-09
56884	SUPPL	2018-12-20
32310	SUPPL	2015-12-08
19382	SUPPL	2015-12-08
24422	ORIG	2012-11-29
22898	ORIG	2012-11-29
32309	ORIG	2012-10-23
23497	ORIG	2012-10-22
19381	ORIG	2012-10-22
51533	ORIG	1900-01-01
51532	ORIG	1900-01-01
51531	ORIG	1900-01-01