Application 201635

Type: NDA
Sponsor: SUPERNUS PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	TROKENDI XR	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	Yes	No
002	TROKENDI XR	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	Yes	No
003	TROKENDI XR	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	Yes	No
004	TROKENDI XR	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	Yes	Yes

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

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	TE codes	RLD / RS	Approval date
N201635-001	TROKENDI XR	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16
N201635-002	TROKENDI XR	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16
N201635-003	TROKENDI XR	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16
N201635-004	TROKENDI XR	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-product	TE code
N201635-001	AB1
N201635-002	AB1
N201635-003	AB1
N201635-004	AB1

Orange Book patents#

Current patent rows page 1 of 1 · 80 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N201635-001	10314790	2027-11-16	U-1675	Drug product	2019-07-09
N201635-001	10314790	2027-11-16	U-1992	Drug product	2019-07-09
N201635-001	8298580	2027-11-16	U-106	Drug product	2013-08-22
N201635-001	8298580	2027-11-16	U-1992	Drug product	2013-08-22
N201635-001	8663683	2027-11-16	U-106	Drug product
N201635-001	8663683	2027-11-16	U-1992	Drug product
N201635-001	8877248	2027-11-16	U-106	Drug product	2014-11-12
N201635-001	8877248	2027-11-16	U-1992	Drug product	2014-11-12
N201635-001	8889191	2027-11-16	U-106		2014-12-17
N201635-001	8889191	2027-11-16	U-1992		2014-12-17
N201635-001	8992989	2027-11-16	U-1675	Drug product	2015-04-08
N201635-001	8992989	2027-11-16	U-1992	Drug product	2015-04-08
N201635-001	9549940	2027-11-16	U-1675	Drug product	2017-01-27
N201635-001	9549940	2027-11-16	U-1992	Drug product	2017-01-27
N201635-001	9555004	2027-11-16	U-1675	Drug product	2017-02-09
N201635-001	9555004	2027-11-16	U-1992	Drug product	2017-02-09
N201635-001	9622983	2027-11-16	U-1675	Drug product	2017-04-20
N201635-001	9622983	2027-11-16	U-1992	Drug product	2017-04-20
N201635-001	8298576	2028-04-04	U-106	Drug product	2013-08-22
N201635-001	8298576	2028-04-04	U-1992	Drug product	2013-08-22
N201635-002	10314790	2027-11-16	U-1675	Drug product	2019-07-09
N201635-002	10314790	2027-11-16	U-1992	Drug product	2019-07-09
N201635-002	8298580	2027-11-16	U-106	Drug product	2013-08-22
N201635-002	8298580	2027-11-16	U-1992	Drug product	2013-08-22
N201635-002	8663683	2027-11-16	U-106	Drug product
N201635-002	8663683	2027-11-16	U-1992	Drug product
N201635-002	8877248	2027-11-16	U-106	Drug product	2014-11-12
N201635-002	8877248	2027-11-16	U-1992	Drug product	2014-11-12
N201635-002	8889191	2027-11-16	U-106		2014-12-17
N201635-002	8889191	2027-11-16	U-1992		2014-12-17
N201635-002	8992989	2027-11-16	U-1675	Drug product	2015-04-08
N201635-002	8992989	2027-11-16	U-1992	Drug product	2015-04-08
N201635-002	9549940	2027-11-16	U-1675	Drug product	2017-01-27
N201635-002	9549940	2027-11-16	U-1992	Drug product	2017-01-27
N201635-002	9555004	2027-11-16	U-1675	Drug product	2017-02-09
N201635-002	9555004	2027-11-16	U-1992	Drug product	2017-02-09
N201635-002	9622983	2027-11-16	U-1675	Drug product	2017-04-20
N201635-002	9622983	2027-11-16	U-1992	Drug product	2017-04-20
N201635-002	8298576	2028-04-04	U-106	Drug product	2013-08-22
N201635-002	8298576	2028-04-04	U-1992	Drug product	2013-08-22
N201635-003	10314790	2027-11-16	U-1675	Drug product	2019-07-09
N201635-003	10314790	2027-11-16	U-1992	Drug product	2019-07-09
N201635-003	8298580	2027-11-16	U-106	Drug product	2013-08-22
N201635-003	8298580	2027-11-16	U-1992	Drug product	2013-08-22
N201635-003	8663683	2027-11-16	U-106	Drug product
N201635-003	8663683	2027-11-16	U-1992	Drug product
N201635-003	8877248	2027-11-16	U-106	Drug product	2014-11-12
N201635-003	8877248	2027-11-16	U-1992	Drug product	2014-11-12
N201635-003	8889191	2027-11-16	U-106		2014-12-17
N201635-003	8889191	2027-11-16	U-1992		2014-12-17
N201635-003	8992989	2027-11-16	U-1675	Drug product	2015-04-08
N201635-003	8992989	2027-11-16	U-1992	Drug product	2015-04-08
N201635-003	9549940	2027-11-16	U-1675	Drug product	2017-01-27
N201635-003	9549940	2027-11-16	U-1992	Drug product	2017-01-27
N201635-003	9555004	2027-11-16	U-1675	Drug product	2017-02-09
N201635-003	9555004	2027-11-16	U-1992	Drug product	2017-02-09
N201635-003	9622983	2027-11-16	U-1675	Drug product	2017-04-20
N201635-003	9622983	2027-11-16	U-1992	Drug product	2017-04-20
N201635-003	8298576	2028-04-04	U-106	Drug product	2013-08-22
N201635-003	8298576	2028-04-04	U-1992	Drug product	2013-08-22
N201635-004	10314790	2027-11-16	U-1675	Drug product	2019-07-09
N201635-004	10314790	2027-11-16	U-1992	Drug product	2019-07-09
N201635-004	8298580	2027-11-16	U-106	Drug product	2013-08-22
N201635-004	8298580	2027-11-16	U-1992	Drug product	2013-08-22
N201635-004	8663683	2027-11-16	U-106	Drug product
N201635-004	8663683	2027-11-16	U-1992	Drug product
N201635-004	8877248	2027-11-16	U-106	Drug product	2014-11-12
N201635-004	8877248	2027-11-16	U-1992	Drug product	2014-11-12
N201635-004	8889191	2027-11-16	U-106		2014-12-17
N201635-004	8889191	2027-11-16	U-1992		2014-12-17
N201635-004	8992989	2027-11-16	U-1675	Drug product	2015-04-08
N201635-004	8992989	2027-11-16	U-1992	Drug product	2015-04-08
N201635-004	9549940	2027-11-16	U-1675	Drug product	2017-01-27
N201635-004	9549940	2027-11-16	U-1992	Drug product	2017-01-27
N201635-004	9555004	2027-11-16	U-1675	Drug product	2017-02-09
N201635-004	9555004	2027-11-16	U-1992	Drug product	2017-02-09
N201635-004	9622983	2027-11-16	U-1675	Drug product	2017-04-20
N201635-004	9622983	2027-11-16	U-1992	Drug product	2017-04-20
N201635-004	8298576	2028-04-04	U-106	Drug product	2013-08-22
N201635-004	8298576	2028-04-04	U-1992	Drug product	2013-08-22

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 · 172 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	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-001	TROKENDI XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-002	TROKENDI XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-003	TROKENDI XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD	2013-08-16	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-004	TROKENDI XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB1	RLD, RS	2013-08-16	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 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	N201635-001	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-003	AB1	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-004	AB1	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N201635-001	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-002	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-003	AB1	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N201635-004	AB1	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N201635-001	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-002	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-003	AB1	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N201635-004	AB1	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-001	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-002	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-003	AB1	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N201635-004	AB1	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N201635-001	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-002	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-003	AB1	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N201635-004	AB1	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-001	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-002	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-003	AB1	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N201635-004	AB1	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-001	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-002	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-003	AB1	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N201635-004	AB1	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-001	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-002	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-003	AB1	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N201635-004	AB1	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-001	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-002	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-003	AB1	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N201635-004	AB1	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-001	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-002	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-003	AB1	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N201635-004	AB1	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 86 · 3,440 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	N201635-001	10314790	2027-11-16	U-1675	Drug product	2019-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	10314790	2027-11-16	U-1992	Drug product	2019-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8298580	2027-11-16	U-1992	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8298580	2027-11-16	U-106	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8663683	2027-11-16	U-1992	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8663683	2027-11-16	U-106	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8877248	2027-11-16	U-1992	Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8877248	2027-11-16	U-106	Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8889191	2027-11-16	U-106		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8889191	2027-11-16	U-1992		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8992989	2027-11-16	U-1675	Drug product	2015-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8992989	2027-11-16	U-1992	Drug product	2015-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9549940	2027-11-16	U-1992	Drug product	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9549940	2027-11-16	U-1675	Drug product	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9555004	2027-11-16	U-1992	Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9555004	2027-11-16	U-1675	Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9622983	2027-11-16	U-1992	Drug product	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	9622983	2027-11-16	U-1675	Drug product	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8298576	2028-04-04	U-106	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-001	8298576	2028-04-04	U-1992	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	10314790	2027-11-16	U-1992	Drug product	2019-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	10314790	2027-11-16	U-1675	Drug product	2019-07-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8298580	2027-11-16	U-106	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8298580	2027-11-16	U-1992	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8663683	2027-11-16	U-106	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8663683	2027-11-16	U-1992	Drug product		`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8877248	2027-11-16	U-1992	Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8877248	2027-11-16	U-106	Drug product	2014-11-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8889191	2027-11-16	U-106		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8889191	2027-11-16	U-1992		2014-12-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8992989	2027-11-16	U-1675	Drug product	2015-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8992989	2027-11-16	U-1992	Drug product	2015-04-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9549940	2027-11-16	U-1992	Drug product	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9549940	2027-11-16	U-1675	Drug product	2017-01-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9555004	2027-11-16	U-1992	Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9555004	2027-11-16	U-1675	Drug product	2017-02-09	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9622983	2027-11-16	U-1992	Drug product	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	9622983	2027-11-16	U-1675	Drug product	2017-04-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8298576	2028-04-04	U-1992	Drug product	2013-08-22	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N201635-002	8298576	2028-04-04	U-106	Drug product	2013-08-22	`84e616aacf4f…`

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 7 of 8 · 153 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	b353e7fb-b976-96d8-e053-2995a90a110a	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Zydus Lifesciences Limited	57016639-89fe-43ad-89c4-5e7a756dddec	2024-08-14		Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Bryant Ranch Prepack	654f7c48-8c5d-4b97-88d6-397696f82b6a	2024-08-08	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	1ef1c408-30f7-51ee-e063-6394a90ac880	2024-08-05	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	e9cb3c29-098c-405f-a200-b436ac7fa1a2	2024-07-24	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals, Inc.	4a656a9f-8eb8-69b7-e054-00144ff8d46c	2024-07-19	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	9ddb8451-a455-87ec-e053-2995a90a5e5e	2024-06-20	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	816566bf-b909-606f-e053-2a91aa0ab8c9	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	NuCare Pharmaceuticals,Inc.	87dc077b-2c84-522b-e053-2995a90a68bc	2024-06-14	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Advanced Rx of Tennessee, LLC	1a16d6a9-3dd1-ede8-e063-6294a90afe75	2024-06-04	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Bryant Ranch Prepack	78ef4e4e-d391-4417-952b-06202d5000d8	2024-04-05	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Advanced Rx Pharmacy of Tennessee, LLC	10a9e6fa-4d55-6b5c-e063-6294a90a608c	2024-02-05	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	A-S Medication Solutions	93da6674-14dc-4c8d-9424-03e4b2b41479	2023-12-12	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	A-S Medication Solutions	f7f2d1bc-9c65-4798-826f-6902b3ec81dc	2023-11-24	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Zydus Lifesciences Limited	9a943af0-1c6d-43c2-830a-f303baa16124	2023-11-08		Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Zydus Lifesciences Limited	57b5d67b-b29b-4c18-a53d-51d5374f3be3	2023-09-28		Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	8bd03bb2-3b9b-4707-a9a4-5618ddc3832f	2023-07-01	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
Topiramate	TOPIRAMATE	Proficient Rx LP	2917ba32-3355-4d64-966a-8518e6fafdbe	2023-06-01	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
topiramate	TOPIRAMATE	Proficient Rx LP	80481455-7ad7-4f44-8113-b8b61d8581a0	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE
TOPIRAMATE	TOPIRAMATE	Proficient Rx LP	a30c583a-4b0a-43a6-ae76-19b1a5e916ca	2022-10-01	Warnings, Adverse reactions	Name fallback generic name: TOPIRAMATE

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 · 36 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
17772-101	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-101	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-101	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-101	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-101	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-101	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-101	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-101	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-101	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-102	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-102	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-102	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-102	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-102	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-102	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-102	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-102	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-102	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-103	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-103	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-103	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-103	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-103	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-103	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-103	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-103	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-103	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-104	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-104	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-104	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-104	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-104	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-104	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-104	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-104	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current
17772-104	Trokendi XR	topiramate	Supernus Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85337	SUPPL	2026-03-12
85300	SUPPL	2026-03-09
85353	SUPPL	2026-03-06
82130	SUPPL	2025-05-01
82129	SUPPL	2025-05-01
81538	SUPPL	2025-03-12
81534	SUPPL	2025-03-11
77201	SUPPL	2024-01-10
77190	SUPPL	2024-01-05
72307	SUPPL	2022-10-11
72306	SUPPL	2022-10-11
72284	SUPPL	2022-10-11
70100	SUPPL	2022-02-07
70099	SUPPL	2022-02-07
70073	SUPPL	2022-02-04
65294	SUPPL	2020-11-19
65279	SUPPL	2020-11-19
65278	SUPPL	2020-11-19
57792	SUPPL	2019-02-22
57774	SUPPL	2019-02-22
50973	SUPPL	2018-01-09
50972	SUPPL	2018-01-04
47955	SUPPL	2017-04-12
47903	SUPPL	2017-04-07
47902	SUPPL	2017-04-07
47901	SUPPL	2017-04-07
45099	SUPPL	2016-08-22
45227	SUPPL	2016-08-18
45141	SUPPL	2016-08-18
40076	SUPPL	2015-06-05
32125	SUPPL	2015-05-13
43369	ORIG	2014-06-24
24397	ORIG	2014-06-24
19027	ORIG	2013-08-21
9914	ORIG	2013-08-20
32124	ORIG	2013-06-11
32123	ORIG	2012-06-26