Application 213426

Type: NDA
Sponsor: ESTEVE PHARMACEUTICALS SA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SEGLENTIS	CELECOXIB;TRAMADOL HYDROCHLORIDE	TABLET;ORAL	56MG;44MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N213426-001	SEGLENTIS	CELECOXIB; TRAMADOL HYDROCHLORIDE	56MG;44MG	TABLET / ORAL		RLD	2021-10-15

Orange Book patents#

Current patent rows page 1 of 1 · 7 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213426-001	10238668	2030-04-19	U-3244	Drug substance, Drug product	2021-11-12
N213426-001	10245276	2030-04-19		Drug substance, Drug product	2021-11-12
N213426-001	10548909	2030-04-19	U-3244		2021-11-12
N213426-001	11478488	2030-04-19	U-3244		2022-11-07
N213426-001	8598152	2030-04-19		Drug substance, Drug product	2021-11-12
N213426-001	9012440	2030-04-19		Drug substance, Drug product	2021-11-12
N213426-001	8846744	2031-06-03		Drug product	2021-11-12

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD, RS	2021-10-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N213426-001	SEGLENTIS	56MG;44MG	TABLET / ORAL	RLD	2021-10-15	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 2 of 7 · 244 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2025-08-23 18:47 UTC	2025-08	N213426-001	9012440	2030-04-19		Drug substance, Drug product	2021-11-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213426-001	8846744	2031-06-03		Drug product	2021-11-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213426-001	10238668	2030-04-19	U-3244	Drug substance, Drug product	2021-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213426-001	10245276	2030-04-19		Drug substance, Drug product	2021-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213426-001	10548909	2030-04-19	U-3244		2021-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213426-001	11478488	2030-04-19	U-3244		2022-11-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213426-001	8598152	2030-04-19		Drug substance, Drug product	2021-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213426-001	9012440	2030-04-19		Drug substance, Drug product	2021-11-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213426-001	8846744	2031-06-03		Drug product	2021-11-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213426-001	10238668	2030-04-19	U-3244	Drug substance, Drug product	2021-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213426-001	10245276	2030-04-19		Drug substance, Drug product	2021-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213426-001	10548909	2030-04-19	U-3244		2021-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213426-001	11478488	2030-04-19	U-3244		2022-11-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213426-001	8598152	2030-04-19		Drug substance, Drug product	2021-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213426-001	9012440	2030-04-19		Drug substance, Drug product	2021-11-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213426-001	8846744	2031-06-03		Drug product	2021-11-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	10238668	2030-04-19	U-3244	Drug substance, Drug product	2021-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	10245276	2030-04-19		Drug substance, Drug product	2021-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	10548909	2030-04-19	U-3244		2021-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	11478488	2030-04-19	U-3244		2022-11-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	8598152	2030-04-19		Drug substance, Drug product	2021-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	9012440	2030-04-19		Drug substance, Drug product	2021-11-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	8846744	2031-06-03		Drug product	2021-11-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	10238668	2030-04-19	U-3244	Drug substance, Drug product	2021-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	10245276	2030-04-19		Drug substance, Drug product	2021-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	10548909	2030-04-19	U-3244		2021-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	11478488	2030-04-19	U-3244		2022-11-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	8598152	2030-04-19		Drug substance, Drug product	2021-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	9012440	2030-04-19		Drug substance, Drug product	2021-11-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	8846744	2031-06-03		Drug product	2021-11-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	10238668	2030-04-19	U-3244	Drug substance, Drug product	2021-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	10245276	2030-04-19		Drug substance, Drug product	2021-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	10548909	2030-04-19	U-3244		2021-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	11478488	2030-04-19	U-3244		2022-11-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	8598152	2030-04-19		Drug substance, Drug product	2021-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	9012440	2030-04-19		Drug substance, Drug product	2021-11-12	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	8846744	2031-06-03		Drug product	2021-11-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213426-001	10238668	2030-04-19	U-3244	Drug substance, Drug product	2021-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213426-001	10245276	2030-04-19		Drug substance, Drug product	2021-11-12	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213426-001	10548909	2030-04-19	U-3244		2021-11-12	`d8e5a09893c0…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213426-001	NP	2024-10-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N213426-001	NP	2024-10-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N213426-001	NP	2024-10-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N213426-001	NP	2024-10-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N213426-001	NP	2024-10-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N213426-001	NP	2024-10-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N213426-001	NP	2024-10-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N213426-001	NP	2024-10-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N213426-001	NP	2024-10-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213426-001	NP	2024-10-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213426-001	NP	2024-10-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213426-001	NP	2024-10-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N213426-001	NP	2024-10-15	`bb7c543d1eb4…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N213426-001	NP	2024-10-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N213426-001	NP	2024-10-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N213426-001	NP	2024-10-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N213426-001	NP	2024-10-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N213426-001	NP	2024-10-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N213426-001	NP	2024-10-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N213426-001	NP	2024-10-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N213426-001	NP	2024-10-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N213426-001	NP	2024-10-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N213426-001	NP	2024-10-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N213426-001	NP	2024-10-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N213426-001	NP	2024-10-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N213426-001	NP	2024-10-15	`cb3db0bc1861…`

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 · 2 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
66869-564	SEGLENTIS	celecoxib and tramadol hydrochloride	Kowa Pharmaceuticals America, Inc.	NDA	Current
66869-564	SEGLENTIS	celecoxib and tramadol hydrochloride	Kowa Pharmaceuticals America, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
80348	SUPPL	2024-11-25
80328	SUPPL	2024-11-22
80327	SUPPL	2024-11-22
80086	SUPPL	2024-11-04
77061	SUPPL	2023-12-19
76982	SUPPL	2023-12-19
76487	ORIG	2023-11-07
73126	SUPPL	2023-01-10
73123	SUPPL	2023-01-09
71554	ORIG	2022-07-15
69030	ORIG	2021-10-19
69015	ORIG	2021-10-18
69014	ORIG	2021-10-18