Application 205122

Type: NDA
Sponsor: UPSHER SMITH LABS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	QUDEXY XR	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	25MG	Yes	No
002	QUDEXY XR	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	50MG	Yes	No
003	QUDEXY XR	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	100MG	Yes	No
004	QUDEXY XR	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	150MG	Yes	No
005	QUDEXY XR	TOPIRAMATE	CAPSULE, EXTENDED RELEASE;ORAL	200MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N205122-001	QUDEXY XR	TOPIRAMATE	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11
N205122-002	QUDEXY XR	TOPIRAMATE	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11
N205122-003	QUDEXY XR	TOPIRAMATE	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11
N205122-004	QUDEXY XR	TOPIRAMATE	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11
N205122-005	QUDEXY XR	TOPIRAMATE	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N205122-001	AB2
N205122-002	AB2
N205122-003	AB2
N205122-004	AB2
N205122-005	AB2

Orange Book patents#

Current patent rows page 1 of 1 · 25 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N205122-001	10363224	2033-03-19	U-766		2019-08-06
N205122-001	8652527	2033-03-19		Drug product	2014-03-12
N205122-001	8889190	2033-03-19		Drug product	2014-11-18
N205122-001	9101545	2033-03-19		Drug product	2015-08-11
N205122-001	9555005	2033-03-19		Drug product	2017-02-02
N205122-002	10363224	2033-03-19	U-766		2019-08-06
N205122-002	8652527	2033-03-19		Drug product	2014-03-12
N205122-002	8889190	2033-03-19		Drug product	2014-11-18
N205122-002	9101545	2033-03-19		Drug product	2015-08-11
N205122-002	9555005	2033-03-19		Drug product	2017-02-02
N205122-003	10363224	2033-03-19	U-766		2019-08-06
N205122-003	8652527	2033-03-19		Drug product	2014-03-12
N205122-003	8889190	2033-03-19		Drug product	2014-11-18
N205122-003	9101545	2033-03-19		Drug product	2015-08-11
N205122-003	9555005	2033-03-19		Drug product	2017-02-02
N205122-004	10363224	2033-03-19	U-766		2019-08-06
N205122-004	8652527	2033-03-19		Drug product	2014-03-12
N205122-004	8889190	2033-03-19		Drug product	2014-11-18
N205122-004	9101545	2033-03-19		Drug product	2015-08-11
N205122-004	9555005	2033-03-19		Drug product	2017-02-02
N205122-005	10363224	2033-03-19	U-766		2019-08-06
N205122-005	8652527	2033-03-19		Drug product	2014-03-12
N205122-005	8889190	2033-03-19		Drug product	2014-11-18
N205122-005	9101545	2033-03-19		Drug product	2015-08-11
N205122-005	9555005	2033-03-19		Drug product	2017-02-02

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 6 · 205 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
2026-02-19 14:30 UTC	2026-02	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 199 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205122-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-005	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N205122-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N205122-005	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N205122-005	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N205122-005	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N205122-005	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-004	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N205122-005	AB2	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-001	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-002	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-003	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-004	AB2	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N205122-005	AB2	1	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,020 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N205122-001	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-001	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-001	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-001	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-001	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-002	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-003	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-004	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	10363224	2033-03-19	U-766		2019-08-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	8652527	2033-03-19		Drug product	2014-03-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	8889190	2033-03-19		Drug product	2014-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	9101545	2033-03-19		Drug product	2015-08-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N205122-005	9555005	2033-03-19		Drug product	2017-02-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	10363224	2033-03-19	U-766		2019-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	8652527	2033-03-19		Drug product	2014-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	8889190	2033-03-19		Drug product	2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	9101545	2033-03-19		Drug product	2015-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-001	9555005	2033-03-19		Drug product	2017-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	10363224	2033-03-19	U-766		2019-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	8652527	2033-03-19		Drug product	2014-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	8889190	2033-03-19		Drug product	2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	9101545	2033-03-19		Drug product	2015-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-002	9555005	2033-03-19		Drug product	2017-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	10363224	2033-03-19	U-766		2019-08-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	8652527	2033-03-19		Drug product	2014-03-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	8889190	2033-03-19		Drug product	2014-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	9101545	2033-03-19		Drug product	2015-08-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N205122-003	9555005	2033-03-19		Drug product	2017-02-02	`31067a03dcf5…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
QUDEXY XR	TOPIRAMATE	Upsher-Smith Laboratories, LLC	46f54677-3a22-4c38-9b92-923020164e15	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205122 application number: NDA205122 ndc (product): 0245-1072 ndc (product): 0245-1071 ndc (product): 0245-1073 ndc (product): 0245-1075 ndc (product): 0245-1074
Topiramate	TOPIRAMATE	Upsher-Smith Laboratories, LLC	691d276c-9cc1-4d39-828f-0f44d7ef6328	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (NDA): 205122 application number: NDA205122 ndc (product): 0832-1072 ndc (product): 0832-1073 ndc (product): 0832-1074 ndc (product): 0832-1075 ndc (product): 0832-1071

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 55 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0245-1071	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1071	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1071	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1071	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1071	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1071	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1072	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1072	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1072	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1072	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1072	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1072	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1073	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1073	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1073	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1073	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1073	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1073	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1074	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1074	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1074	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1074	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1074	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1074	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1075	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1075	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1075	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1075	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1075	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0245-1075	QUDEXY	Topiramate	Upsher-Smith Laboratories, LLC	NDA	Current
0832-1071	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1071	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1071	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1071	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1071	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1072	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1072	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1072	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1072	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1072	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1073	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1073	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1073	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1073	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1073	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1074	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1074	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1074	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1074	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1074	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1075	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1075	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1075	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1075	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current
0832-1075	Topiramate	Topiramate	Upsher-Smith Laboratories, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
85338	SUPPL	2026-03-12
85304	SUPPL	2026-03-09
85356	SUPPL	2026-03-06
81585	SUPPL	2025-03-17
81563	SUPPL	2025-03-14
78024	SUPPL	2024-04-01
78004	SUPPL	2024-03-28
72790	SUPPL	2022-12-05
72789	SUPPL	2022-12-05
72788	SUPPL	2022-12-05
70119	SUPPL	2022-02-08
70118	SUPPL	2022-02-08
70111	SUPPL	2022-02-08
66307	SUPPL	2021-02-22
66299	SUPPL	2021-02-19
61910	SUPPL	2020-02-19
61909	SUPPL	2020-02-19
61907	SUPPL	2020-02-18
57791	SUPPL	2019-02-22
57790	SUPPL	2019-02-22
57775	SUPPL	2019-02-22
47793	SUPPL	2017-03-30
47792	SUPPL	2017-03-30
47783	SUPPL	2017-03-30
47782	SUPPL	2017-03-30
47781	SUPPL	2017-03-30
47780	SUPPL	2017-03-30
10428	SUPPL	2016-04-20
44915	ORIG	2015-05-14
22976	ORIG	2015-05-14
10427	SUPPL	2015-04-02
40448	SUPPL	2015-04-01
40447	ORIG	2014-03-13
32634	ORIG	2014-03-13