Application 206827

Type: ANDA
Sponsor: AUROBINDO PHARMA 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
A206827-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01
A206827-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01
A206827-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01
A206827-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206827-001	AB
A206827-002	AB
A206827-003	AB
A206827-004	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	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206827-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2016-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206827-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2016-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206827-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2016-02-01	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206827-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2016-02-01	`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	A206827-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A206827-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206827-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206827-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206827-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206827-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206827-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206827-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206827-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206827-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206827-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206827-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206827-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206827-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206827-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206827-004	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	REMEDYREPACK INC.	e18d2fa4-4982-4e2a-af55-4319d6416efb	2026-08-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206827 application number: ANDA206827
Celecoxib	CELECOXIB	NCS HealthCare of KY, LLC dba Vangard Labs	34bef49c-eca1-4f17-9b1b-55900ac40829	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206827 application number: ANDA206827
Celecoxib	CELECOXIB	Aurobindo Pharma Limited	1e811c3a-5653-4617-b958-380802cc443a	2024-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206827 application number: ANDA206827 ndc (product): 65862-907 ndc (product): 65862-909 ndc (product): 65862-908 ndc (product): 65862-910

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 26 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2427	Celecoxib	Celecoxib	A-S Medication Solutions	ANDA	Current
55700-429	Celecoxib	Celecoxib	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
55700-430	Celecoxib	Celecoxib	Lake Erie Medical DBA Quality Care Products LLC	ANDA	Current
65862-907	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-907	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-907	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-907	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-907	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-908	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-908	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-908	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-908	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-908	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-909	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-909	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-909	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-909	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-909	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-910	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-910	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-910	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-910	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
65862-910	Celecoxib	Celecoxib	Aurobindo Pharma Limited	ANDA	Current
68788-6463	Celecoxib	Celecoxib	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6463	Celecoxib	Celecoxib	Preferred Pharmaceuticals Inc.	ANDA	Current
70882-129	Celecoxib	Celecoxib	Cambridge Therapeutics Technologies, LLC	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
40565	ORIG	2016-02-11
10596	ORIG	2016-02-03