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 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	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 · 129 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
2026-09-14 22:38:34	2026-08	N202810-001	OXTELLAR XR	150MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	OXTELLAR XR	300MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD	2012-10-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	OXTELLAR XR	600MG	TABLET, EXTENDED RELEASE / ORAL	AB	RLD, RS	2012-10-19	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 54 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N202810-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	AB	1	`84e616aacf4f…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 33 · 1,320 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	N202810-001	10220042	2027-04-13	U-2501		2019-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	11166960	2027-04-13		Drug product	2021-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	11896599	2027-04-13		Drug product	2024-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	7722898	2027-04-13		Drug product	2012-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	7910131	2027-04-13	U-2041		2012-11-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	8617600	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	8821930	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	9119791	2027-04-13	U-2041		2015-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	9351975	2027-04-13		Drug product	2016-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	9370525	2027-04-13		Drug product	2016-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-001	9855278	2027-04-13		Drug product	2018-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	10220042	2027-04-13	U-2501		2019-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	11166960	2027-04-13		Drug product	2021-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	11896599	2027-04-13		Drug product	2024-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	7722898	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	7910131	2027-04-13	U-2041			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	8617600	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	8821930	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	9119791	2027-04-13	U-2041		2015-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	9351975	2027-04-13		Drug product	2016-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	9370525	2027-04-13		Drug product	2016-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-002	9855278	2027-04-13		Drug product	2018-01-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	10220042	2027-04-13	U-2501		2019-03-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	11166960	2027-04-13		Drug product	2021-11-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	11896599	2027-04-13		Drug product	2024-02-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	7722898	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	7910131	2027-04-13	U-2041			`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	8617600	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	8821930	2027-04-13		Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	9119791	2027-04-13	U-2041		2015-09-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	9351975	2027-04-13		Drug product	2016-06-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	9370525	2027-04-13		Drug product	2016-06-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N202810-003	9855278	2027-04-13		Drug product	2018-01-05	`84e616aacf4f…`
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…`

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 4 · 72 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Oxcarbazepine	OXCARBAZEPINE	Zameer Pharmaceuticals LLC	8841174a-9f4b-424f-a50d-01478f2aeb29	2026-08-26	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Cardinal Health 107, LLC	4ebcb0e5-1c93-4b3f-8749-6835c56afce5	2026-08-12	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a2032bcc-2da5-45e5-aa3f-ddbf50909df8	2026-08-05	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	a90cd1f1-5258-4b0e-92fd-c4cebe47772b	2026-08-04	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	ffc8d10c-0049-4fe5-beb8-79cc6a197ede	2026-07-23	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	b571ee0f-3c2a-4c55-9c2b-e00014e2ec7a	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Cardinal Health 107, LLC	3e0f8d9f-7659-4524-8f93-6200314356c8	2026-07-21	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	ANI Pharmaceuticals, Inc.	867eaf99-3e31-4f75-bfae-2898804d956d	2026-07-13	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	85a9bdee-4d10-4097-ae3d-0bf8d844a11b	2026-07-08	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	American Health Packaging	c0f9df3f-280e-4394-8d7e-ad04803b2635	2026-07-02	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Major Pharmaceuticals	b1d54def-057d-4608-bc8f-1d967ac3ec91	2026-06-15	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
oxcarbazepine	OXCARBAZEPINE	Zydus Lifesciences Limited	e23d8a74-b47b-462a-b09c-90bdd58a032e	2026-06-13	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
oxcarbazepine	OXCARBAZEPINE	Zydus Pharmaceuticals (USA) Inc.	5048dc87-2d89-434d-be51-4a97b0ce0601	2026-06-13	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	c7718f8b-63e2-40b9-b519-e687cfc2cacf	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	188a48ad-c412-416a-b15b-de5f232740a2	2026-06-11	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	REMEDYREPACK INC.	0abe9478-4084-286d-e063-6294a90a9ba7	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	REMEDYREPACK INC.	fcf5044a-8cfd-47d5-9f47-8f6674843c24	2026-06-08	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	Sun Pharmaceutical Industries, Inc.	7ecd5eef-46f4-407f-9b63-ba65adb3eced	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
OXCARBAZEPINE	OXCARBAZEPINE	Camber Pharmaceuticals, Inc.	a18f591b-587e-4769-8ac2-9cfba0b82526	2026-05-22	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE
Oxcarbazepine	OXCARBAZEPINE	ASCLEMED USA INC.	c42b2cb2-8b45-488b-bf63-81909a1f06cb	2026-05-19	Warnings, Adverse reactions	Name fallback generic name: OXCARBAZEPINE

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 · 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