Application 202240

Type: ANDA
Sponsor: LUPIN 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
A202240-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29
A202240-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09
A202240-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09
A202240-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202240-001	AB
A202240-002	AB
A202240-003	AB
A202240-004	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	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202240-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2014-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202240-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2015-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202240-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2015-06-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202240-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2015-06-09	`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	A202240-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202240-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202240-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202240-004	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A202240-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202240-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202240-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202240-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202240-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202240-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202240-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202240-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202240-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202240-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202240-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202240-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202240-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202240-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202240-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202240-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202240-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202240-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202240-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202240-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202240-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202240-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202240-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202240-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202240-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202240-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202240-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202240-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202240-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202240-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202240-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202240-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202240-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202240-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202240-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202240-004	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
celecoxib	CELECOXIB	Lupin Pharmaceuticals, Inc.	560017b1-daf8-464e-b86f-0a75c78002ec	2023-12-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202240 application number: ANDA202240 ndc (product): 68180-396 ndc (product): 68180-397 ndc (product): 68180-398 ndc (product): 68180-395 ndc (product): 68180-399
celecoxib	CELECOXIB	A-S Medication Solutions	85bfe02b-bfcb-44ee-81a0-11765c3054a9	2023-02-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202240 application number: ANDA202240 ndc (product): 50090-5638

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
0615-8297	celecoxib	celecoxib	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8297	celecoxib	celecoxib	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-8338	celecoxib	celecoxib	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
50090-5638	celecoxib	celecoxib	A-S Medication Solutions	ANDA	Current
68180-395	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-395	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-395	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-395	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-395	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-396	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-396	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-396	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-396	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-396	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-397	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-397	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-397	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-397	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-398	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-398	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-398	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-398	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-398	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-399	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-399	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current
68180-399	celecoxib	celecoxib	Lupin Pharmaceuticals, Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19299	ORIG	2015-06-19
9995	ORIG	2015-06-11
32213	ORIG	2015-04-10