Application 204197

Type: ANDA
Sponsor: APOTEX INC

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 42.

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
A204197-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02
A204197-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02
A204197-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204197-001	AB
A204197-002	AB
A204197-003	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 · 126 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	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204197-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-06-02	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 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	A204197-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204197-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204197-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204197-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204197-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204197-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204197-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204197-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204197-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204197-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204197-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204197-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204197-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204197-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204197-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204197-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204197-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204197-001	AB	1	`1e350fbaab3a…`

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Bryant Ranch Prepack	d94849a7-1831-4319-982c-c6b20dc42038	2026-06-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197 ndc (product): 71335-0292
Celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	52572bfb-43f0-4b55-b1fd-231a05c8b83e	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197 ndc (product): 43063-825
Celecoxib	CELECOXIB	Apotex Corp.	a62612b3-9564-2b34-be59-6aa5ac53679c	2026-04-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197 ndc (product): 60505-3848 ndc (product): 60505-3849 ndc (product): 60505-3847
Celecoxib	CELECOXIB	A-S Medication Solutions	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	2024-09-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197 ndc (product): 50090-5178
Celecoxib	CELECOXIB	Proficient Rx LP	6dd743d3-4821-4919-90eb-6d306ca7999f	2021-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204197 application number: ANDA204197 ndc (product): 63187-562

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 75 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6502	Celecoxib	Celecoxib	Major Pharmaceuticals	ANDA	Current
0904-6502	Celecoxib	Celecoxib	Major Pharmaceuticals	ANDA	Current
0904-6502	Celecoxib	Celecoxib	Major Pharmaceuticals	ANDA	Current
0904-6502	Celecoxib	Celecoxib	Major Pharmaceuticals	ANDA	Current
0904-6503	Celecoxib	Celecoxib	Major Pharmaceuticals	ANDA	Current
0904-6503	Celecoxib	Celecoxib	Major Pharmaceuticals	ANDA	Current
0904-6503	Celecoxib	Celecoxib	Major Pharmaceuticals	ANDA	Current
0904-6503	Celecoxib	Celecoxib	Major Pharmaceuticals	ANDA	Current
10544-953	Celecoxib	Celecoxib	Blenheim Pharmacal, Inc.	ANDA	Current
33358-902	Celecoxib	Celecoxib	RxChange Co.	ANDA	Current
43063-825	Celecoxib	Celecoxib	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-825	Celecoxib	Celecoxib	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-825	Celecoxib	Celecoxib	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-825	Celecoxib	Celecoxib	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
43063-825	Celecoxib	Celecoxib	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
50090-5178	Celecoxib	Celecoxib	A-S Medication Solutions	ANDA	Current
50090-5178	Celecoxib	Celecoxib	A-S Medication Solutions	ANDA	Current
50436-3849	Celecoxib	Celecoxib	Unit Dose Services	ANDA	Current
55154-7645	Celecoxib	Celecoxib	Cardinal Health 107, LLC	ANDA	Current
55154-7645	Celecoxib	Celecoxib	Cardinal Health	ANDA	Current
55154-7645	Celecoxib	Celecoxib	Cardinal Health	ANDA	Current
55154-7645	Celecoxib	Celecoxib	Cardinal Health	ANDA	Current
55154-7646	Celecoxib	Celecoxib	Cardinal Health 107, LLC	ANDA	Current
55154-7646	Celecoxib	Celecoxib	Cardinal Health	ANDA	Current
55154-7646	Celecoxib	Celecoxib	Cardinal Health	ANDA	Current
55154-7646	Celecoxib	Celecoxib	Cardinal Health	ANDA	Current
60505-3847	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3847	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3847	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3847	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3848	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3848	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3848	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3848	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3849	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3849	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3849	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60505-3849	Celecoxib	Celecoxib	Apotex Corp.	ANDA	Current
60760-209	Celecoxib	Celecoxib	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-209	Celecoxib	Celecoxib	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-849	Celecoxib	Celecoxib	St. Mary's Medical Park Pharmacy	ANDA	Current
60760-849	Celecoxib	Celecoxib	St. Mary's Medical Park Pharmacy	ANDA	Current
61919-043	CELECOXIB	CELECOXIB	Direct_Rx	ANDA	Current
61919-360	CELECOXIB	CELECOXIB	DIRECT RX	ANDA	Current
61919-360	CELECOXIB	CELECOXIB	DIRECT RX	ANDA	Current
61919-360	CELECOXIB	CELECOXIB	DIRECT RX	ANDA	Current
61919-360	CELECOXIB	CELECOXIB	Direct_Rx	ANDA	Current
61919-360	CELECOXIB	CELECOXIB	Direct_Rx	ANDA	Current
61919-360	CELECOXIB	CELECOXIB	Direct_Rx	ANDA	Current
61919-360	CELECOXIB	CELECOXIB	Direct_Rx	ANDA	Current
63187-562	Celecoxib	Celecoxib	Proficient Rx LP	ANDA	Current
63187-562	Celecoxib	Celecoxib	Proficient Rx LP	ANDA	Current
67296-1608	Celecoxib	Celecoxib	RedPharm Drug, Inc.	ANDA	Current
67296-1608	Celecoxib	Celecoxib	RedPharm Drug, Inc.	ANDA	Current
67296-1608	Celecoxib	Celecoxib	RedPharm Drug, Inc.	ANDA	Current
68071-2164	Celecoxib	Celecoxib	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2169	Celecoxib	Celecoxib	NuCare Pharmaceuticals, Inc.	ANDA	Current
68071-4252	Celecoxib	Celecoxib	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6941	Celecoxib	Celecoxib	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6941	Celecoxib	Celecoxib	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7134	Celecoxib	Celecoxib	Preferred Pharmaceuticals Inc	ANDA	Current
68788-7134	Celecoxib	Celecoxib	Preferred Pharmaceuticals Inc	ANDA	Current
68788-7134	Celecoxib	Celecoxib	Preferred Pharmaceuticals Inc	ANDA	Current
69677-154	Celecoxib	Celecoxib	Mas Management Group, Inc.	ANDA	Current
70859-029	NuDroxiPAK	Celecoxib,Methyl Salicylate/Menthol/Capsaicin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-029	NuDroxiPAK	Celecoxib,Methyl Salicylate/Menthol/Capsaicin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70859-029	NuDroxiPAK	Celecoxib,Methyl Salicylate/Menthol/Capsaicin	NuCare Pharmaceuticals,Inc.	ANDA	Current
70934-026	Celecoxib	Celecoxib	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-026	Celecoxib	Celecoxib	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-026	Celecoxib	Celecoxib	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
70934-026	Celecoxib	Celecoxib	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	ANDA	Current
71335-0292	Celecoxib	Celecoxib	Bryant Ranch Prepack	ANDA	Current
71335-0292	Celecoxib	Celecoxib	Bryant Ranch Prepack	ANDA	Current
71335-0292	Celecoxib	Celecoxib	Bryant Ranch Prepack	ANDA	Current
71335-0361	Celecoxib	Celecoxib	Bryant Ranch Prepack	ANDA	Current