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 43.

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 · 129 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
2026-09-14 22:38:34	2026-08	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210071-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2018-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210071-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2018-01-23	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210071-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2018-01-23	`caaa826d4ba7…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A210071-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210071-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210071-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210071-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210071-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210071-003	AB	1	`caaa826d4ba7…`
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…`

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 2 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Celecoxib	CELECOXIB	A-S Medication Solutions	dea035a6-dcf1-4b7d-8adc-a2f678b71fd9	2023-08-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210071 application number: ANDA210071

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 · 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