Application 207872

Type: ANDA
Sponsor: TIANJIN TIANYAO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CELECOXIB	CELECOXIB	CAPSULE;ORAL	50MG	No	No
002	CELECOXIB	CELECOXIB	CAPSULE;ORAL	100MG	No	No
003	CELECOXIB	CELECOXIB	CAPSULE;ORAL	200MG	No	No
004	CELECOXIB	CELECOXIB	CAPSULE;ORAL	400MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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	Approval date
A207872-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25
A207872-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25
A207872-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25
A207872-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207872-001	AB
A207872-002	AB
A207872-003	AB
A207872-004	AB

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 · 152 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-02-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-02-25	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 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	A207872-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207872-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207872-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207872-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207872-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207872-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207872-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207872-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207872-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207872-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207872-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207872-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207872-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207872-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207872-004	AB	1	`d8e5a09893c0…`

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
Celecoxib	CELECOXIB	EPIC PHARMA, LLC	ac670924-0a3f-4f94-ac01-9e3c3071c990	2025-01-07	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207872 application number: ANDA207872 ndc (product): 42806-722 ndc (product): 42806-720 ndc (product): 42806-723 ndc (product): 42806-721
Celecoxib	CELECOXIB	Tianjin Tianyao Pharmaceuticals Co., Ltd.	76f9bcb7-0e94-485f-816d-61d4e1ed24e0	2022-02-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207872 application number: ANDA207872 ndc (product): 57582-213 ndc (product): 57582-214 ndc (product): 57582-212 ndc (product): 57582-211

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42806-720	Celecoxib	Celecoxib	EPIC PHARMA, LLC	ANDA	Current
42806-720	Celecoxib	Celecoxib	EPIC PHARMA, LLC	ANDA	Current
42806-721	Celecoxib	Celecoxib	EPIC PHARMA, LLC	ANDA	Current
42806-721	Celecoxib	Celecoxib	EPIC PHARMA, LLC	ANDA	Current
42806-722	Celecoxib	Celecoxib	EPIC PHARMA, LLC	ANDA	Current
42806-722	Celecoxib	Celecoxib	EPIC PHARMA, LLC	ANDA	Current
42806-723	Celecoxib	Celecoxib	EPIC PHARMA, LLC	ANDA	Current
42806-723	Celecoxib	Celecoxib	EPIC PHARMA, LLC	ANDA	Current
57582-211	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-211	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-211	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-212	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-212	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-212	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-213	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-213	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-213	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-214	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-214	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current
57582-214	Celecoxib	Celecoxib	Tianjin Tianyao Pharmaceuticals Co., Ltd.	ANDA	Current