Application 208701

Type: ANDA
Sponsor: CADILA PHARMS LTD

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
A208701-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14
A208701-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14
A208701-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14
A208701-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208701-001	AB
A208701-002	AB
A208701-003	AB
A208701-004	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 · 156 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	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208701-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208701-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208701-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208701-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-14	`d8e5a09893c0…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 156 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	A208701-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208701-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208701-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208701-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208701-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208701-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208701-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208701-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208701-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208701-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208701-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208701-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208701-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208701-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208701-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208701-004	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	REMEDYREPACK INC.	56d64558-1fad-420e-8fcd-7103cd073127	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208701 application number: ANDA208701
Celecoxib	CELECOXIB	Modavar Pharmaceuticals LLC	b0f73074-f3d8-4812-8e64-f88a02869ed3	2024-12-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208701 application number: ANDA208701 ndc (product): 72241-024 ndc (product): 72241-025 ndc (product): 72241-023 ndc (product): 72241-022
Celecoxib	CELECOXIB	Cadila Pharmaceuticals Limited	78ce3df5-07ee-43bb-9348-104a9524a032	2024-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208701 application number: ANDA208701 ndc (product): 71209-056 ndc (product): 71209-055 ndc (product): 71209-054 ndc (product): 71209-057
Celecoxib	CELECOXIB	Bryant Ranch Prepack	1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a6	2024-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208701 application number: ANDA208701

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 32 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
71209-054	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-054	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-054	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-054	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-054	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-055	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-055	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-055	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-055	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-055	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-056	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-056	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-056	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-056	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-056	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-057	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-057	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-057	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-057	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
71209-057	Celecoxib	Celecoxib	Cadila Pharmaceuticals Limited	ANDA	Current
72241-022	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-022	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-022	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-023	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-023	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-023	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-024	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-024	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-024	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-025	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-025	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current
72241-025	Celecoxib	Celecoxib	Modavar Pharmaceuticals LLC	ANDA	Current