Application 210071

Type: ANDA
Sponsor: CSPC OUYI

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

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A210071-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23
A210071-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23
A210071-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A210071-001	AB
A210071-002	AB
A210071-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A210071-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210071-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210071-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210071-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210071-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210071-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210071-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210071-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210071-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210071-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210071-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210071-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210071-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210071-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210071-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210071-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210071-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210071-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210071-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210071-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210071-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210071-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210071-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210071-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210071-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210071-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210071-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210071-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210071-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210071-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210071-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210071-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210071-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210071-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210071-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210071-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210071-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210071-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210071-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210071-001	AB	1	`8072bd15b7f6…`

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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	St. Mary's Medical Park Pharmacy	57b07096-6d7c-1653-e063-6294a90aa6e2	2026-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	St. Mary's Medical Park Pharmacy	3bc74e76-0517-69c6-e063-6394a90abe75	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	REMEDYREPACK INC.	f5d0e5b9-97d8-42a4-a0a0-c09dde7008e6	2026-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Redpharm Drug	5250529a-6a03-78a1-e063-6294a90a47f9	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Direct_Rx	4b2ffbdb-1847-d93b-e063-6394a90a06f5	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Northwind Health Company, LLC	0de7a6f8-baba-1fd0-e063-6394a90ad434	2026-04-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	ST. MARY'S MEDICAL PARK PHARMACY	4e57bd99-5b7a-c2c7-e063-6294a90afb8c	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Preferred Pharmaceuticals Inc.	b0839895-6a36-4e4f-9336-98632b60622a	2026-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Mullan Pharmaceutical Inc.	643e177f-216d-4dfa-824a-7516a488304e	2026-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	eca923da-59fa-da2e-e053-2a95a90a6a51	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071 ndc (product): 80425-0209
Celecoxib	CELECOXIB	Preferred Pharmaceutical Inc.	7f20976d-bed3-4a06-9aaf-f5b5240e4ce3	2026-03-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	REMEDYREPACK INC.	7de31e90-2eaf-46cd-a058-3946b029d88c	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	REMEDYREPACK INC.	c96509cc-47f4-44f8-9f7e-4e49cc3d5348	2025-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Proficient Rx LP	3a450db8-313c-4120-9b8e-58c956323fa4	2025-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Bryant Ranch Prepack	a9749f00-0307-4842-a95b-9a8b4989df25	2025-02-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Cranbury Pharmaceuticals, LLC	933532fa-044a-48b1-bbe4-28062564f98a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f8fdcc56-7a53-9a42-e053-6394a90a48d5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	Westminster Pharmaceuticals, LLC	cb0be640-067e-4422-9bec-d5fa07175bd0	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071 ndc (product): 69367-301 ndc (product): 69367-302
Celecoxib	CELECOXIB	A-S Medication Solutions	85b87dd2-c609-4d69-99eb-0acd852acdaf	2024-08-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071
Celecoxib	CELECOXIB	NuCare Pharmaceuticals, Inc.	1cbe21c0-3425-9a25-e063-6294a90a0d1d	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 15 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69367-301	Celecoxib	Celecoxib	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-301	Celecoxib	Celecoxib	Westminster Pharmaceuticals	ANDA	Current
69367-301	Celecoxib	Celecoxib	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-301	Celecoxib	Celecoxib	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-302	Celecoxib	Celecoxib	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-302	Celecoxib	Celecoxib	Westminster Pharmaceuticals	ANDA	Current
69367-302	Celecoxib	Celecoxib	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-302	Celecoxib	Celecoxib	Westminster Pharmaceuticals, LLC	ANDA	Current
71626-301	Celecoxib	Celecoxib	Medstone Pharma LLC	ANDA	Current
71626-301	Celecoxib	Celecoxib	Medstone Pharma LLC	ANDA	Current
71626-302	Celecoxib	Celecoxib	Medstone Pharma LLC	ANDA	Current
71626-302	Celecoxib	Celecoxib	Medstone Pharma LLC	ANDA	Current
71626-303	Celecoxib	Celecoxib	Medstone Pharma LLC	ANDA	Current
71626-303	Celecoxib	Celecoxib	Medstone Pharma LLC	ANDA	Current
80425-0209	Celecoxib	Celecoxib	Advanced Rx Pharmacy of Tennessee, LLC	ANDA	Current