Application 205129

Type: ANDA
Sponsor: SCIEGEN PHARMS 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 1.

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
A205129-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03
A205129-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03
A205129-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03
A205129-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205129-001	AB
A205129-002	AB
A205129-003	AB
A205129-004	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 · 144 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	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205129-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-12-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2020-12-03	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 144 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	A205129-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205129-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205129-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205129-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205129-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205129-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205129-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205129-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205129-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205129-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205129-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205129-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205129-004	AB	1	`d06236e962d9…`

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 · 24 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Medsource Pharmaceuticals	14962aef-7609-b29a-e063-6394a90a5399	2024-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Bryant Ranch Prepack	631154cd-8f61-41b2-a686-80edc711cdaa	2024-02-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129
Celecoxib	CELECOXIB	Proficient Rx LP	b9a7f32c-8136-4f29-be6b-4d5e904ca0f1	2023-05-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129 ndc (product): 71205-664
Celecoxib	CELECOXIB	Aphena Pharma Solutions - Tennessee, LLC	d258e065-e9a6-44e2-89c9-6892d771d9d3	2021-08-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205129 application number: ANDA205129 ndc (product): 71610-584

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-156	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-156	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-156	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-156	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-157	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-157	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-157	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-157	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-158	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-158	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-158	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-158	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-159	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-159	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-159	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
50228-159	Celecoxib	Celecoxib	ScieGen Pharmaceuticals, Inc.	ANDA	Current
60760-649	Celecoxib	Celecoxib	ST. MARY'S MEDICAL PARK PHARMACY	ANDA	Current
60760-742	Celecoxib	Celecoxib	St Mary's Medical Park Pharmacy	ANDA	Current
60760-742	Celecoxib	Celecoxib	St Mary's Medical Park Pharmacy	ANDA	Current
60760-742	Celecoxib	Celecoxib	St Mary's Medical Park Pharmacy	ANDA	Current
68071-2733	Celecoxib	Celecoxib	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-2776	Celecoxib	Celecoxib	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-8197	Celecoxib	Celecoxib	Preferred Pharmaceuticals, Inc.	ANDA	Current
71205-664	Celecoxib	Celecoxib	Proficient Rx LP	ANDA	Current
71610-584	Celecoxib	Celecoxib	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
72189-360	Celecoxib	Celecoxib	DirectRx	ANDA	Current
72789-259	Celecoxib	Celecoxib	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-259	Celecoxib	Celecoxib	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-259	Celecoxib	Celecoxib	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
72789-259	Celecoxib	Celecoxib	PD-Rx Pharmaceuticals, Inc.	ANDA	Current
77771-156	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-156	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-156	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-156	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-156	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-157	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-157	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-157	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-157	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-157	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-158	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-158	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-158	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-158	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-158	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-159	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-159	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-159	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-159	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current
77771-159	Celecoxib	Celecoxib	Radha Pharmaceuticals, Inc.	ANDA	Current