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 42.

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 · 210 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	N205122-001	QUDEXY XR	25MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-002	QUDEXY XR	50MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-003	QUDEXY XR	100MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-004	QUDEXY XR	150MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD	2014-03-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-005	QUDEXY XR	200MG	CAPSULE, EXTENDED RELEASE / ORAL	AB2	RLD, RS	2014-03-11	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 204 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	N205122-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-005	AB2	1	`caaa826d4ba7…`
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…`

Observed Orange Book patent history#

Patent history page 1 of 27 · 1,045 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	N205122-001	10363224	2033-03-19	U-766		2019-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-001	8652527	2033-03-19		Drug product	2014-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-001	8889190	2033-03-19		Drug product	2014-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-001	9101545	2033-03-19		Drug product	2015-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-001	9555005	2033-03-19		Drug product	2017-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-002	10363224	2033-03-19	U-766		2019-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-002	8652527	2033-03-19		Drug product	2014-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-002	8889190	2033-03-19		Drug product	2014-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-002	9101545	2033-03-19		Drug product	2015-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-002	9555005	2033-03-19		Drug product	2017-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-003	10363224	2033-03-19	U-766		2019-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-003	8652527	2033-03-19		Drug product	2014-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-003	8889190	2033-03-19		Drug product	2014-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-003	9101545	2033-03-19		Drug product	2015-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-003	9555005	2033-03-19		Drug product	2017-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-004	10363224	2033-03-19	U-766		2019-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-004	8652527	2033-03-19		Drug product	2014-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-004	8889190	2033-03-19		Drug product	2014-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-004	9101545	2033-03-19		Drug product	2015-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-004	9555005	2033-03-19		Drug product	2017-02-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-005	10363224	2033-03-19	U-766		2019-08-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-005	8652527	2033-03-19		Drug product	2014-03-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-005	8889190	2033-03-19		Drug product	2014-11-18	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-005	9101545	2033-03-19		Drug product	2015-08-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N205122-005	9555005	2033-03-19		Drug product	2017-02-02	`caaa826d4ba7…`
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…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topiramate	TOPIRAMATE	Upsher-Smith Laboratories, LLC	691d276c-9cc1-4d39-828f-0f44d7ef6328	2026-05-15	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
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

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