Application 200562

Type: ANDA
Sponsor: WATSON LABS 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
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
A200562-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11
A200562-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11
A200562-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11
A200562-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A200562-001	AB
A200562-002	AB
A200562-003	AB
A200562-004	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 5 · 168 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	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2015-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-02-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-02-11	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 168 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	A200562-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A200562-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200562-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A200562-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200562-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200562-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A200562-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200562-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200562-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200562-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200562-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200562-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200562-004	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Actavis Pharma, Inc.	05224473-27dc-4f6d-a52a-c40a7af2f2f4	2025-04-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200562 application number: ANDA200562 ndc (product): 0591-3984 ndc (product): 0591-3985 ndc (product): 0591-3982 ndc (product): 0591-3983
Celecoxib	CELECOXIB	Asclemed USA, Inc.	265b50cc-6d99-4ef8-8439-6792e1f21c68	2024-05-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200562 application number: ANDA200562
Celecoxib	CELECOXIB	Proficient Rx LP	c529b321-38ed-434f-b76e-06902cdd40dc	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200562 application number: ANDA200562 ndc (product): 63187-643

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 31 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0591-3982	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3982	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3982	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3982	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3982	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3983	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3983	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3983	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3983	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3983	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3984	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3984	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3984	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3984	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3984	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3985	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3985	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3985	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3985	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
0591-3985	Celecoxib	Celecoxib	Actavis Pharma, Inc.	ANDA	Current
50436-3983	Celecoxib	Celecoxib	Unit Dose Services	ANDA	Current
50436-3983	Celecoxib	Celecoxib	Unit Dose Services	ANDA	Current
50436-3984	Celecoxib	Celecoxib	Unit Dose Services	ANDA	Current
50436-3984	Celecoxib	Celecoxib	Unit Dose Services	ANDA	Current
55700-337	Celecoxib	Celecoxib	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
63187-643	Celecoxib	Celecoxib	Proficient Rx LP	ANDA	Current
63187-643	Celecoxib	Celecoxib	Proficient Rx LP	ANDA	Current
63187-643	Celecoxib	Celecoxib	Proficient Rx LP	ANDA	Current
63187-643	Celecoxib	Celecoxib	Proficient Rx LP	ANDA	Current
68788-8936	Celecoxib	Celecoxib	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0597	Celecoxib	Celecoxib	Bryant Ranch Prepack	ANDA	Current