Application 210628

Type: ANDA
Sponsor: UMEDICA LABS PVT 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 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
A210628-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27
A210628-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27
A210628-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27
A210628-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210628-001	AB
A210628-002	AB
A210628-003	AB
A210628-004	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 · 152 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	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210628-001	CELECOXIB	50MG	CAPSULE / ORAL	AB	2019-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210628-002	CELECOXIB	100MG	CAPSULE / ORAL	AB	2019-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210628-003	CELECOXIB	200MG	CAPSULE / ORAL	AB	2019-11-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210628-004	CELECOXIB	400MG	CAPSULE / ORAL	AB	2019-11-27	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 152 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	A210628-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210628-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210628-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210628-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210628-004	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210628-004	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210628-004	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210628-004	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210628-004	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210628-004	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210628-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210628-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210628-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210628-004	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210628-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210628-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210628-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210628-004	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 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	fd569104-8243-48fa-8e93-5a08654ad6dd	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628 ndc (product): 71335-2019
CELECOXIB	CELECOXIB	REMEDYREPACK INC.	d0ca85fa-8b80-4a48-a1a4-a1c181821c39	2026-04-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628 ndc (product): 70518-3424
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	47be1d99-eebb-42f9-80d9-291a024b1364	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628
CELECOXIB	CELECOXIB	Umedica Laboratories USA Inc.	b0e0243e-59b3-4f73-8c21-86b60fc7894b	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628 ndc (product): 60290-018 ndc (product): 60290-019 ndc (product): 60290-017 ndc (product): 60290-016
CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ae7943ab-b1fc-f08f-e053-2995a90a051e	2026-01-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628 ndc (product): 75834-237 ndc (product): 75834-239 ndc (product): 75834-236 ndc (product): 75834-238
CELECOXIB	CELECOXIB	PHOENIX RX LLC	3a669c28-fbc7-827c-e063-6394a90a0829	2025-08-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f60394f5-fd69-929b-e053-2995a90a5793	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210628 application number: ANDA210628

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 38 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
60290-016	CELECOXIB	CELECOXIB	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
60290-016	CELECOXIB	CELECOXIB	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
60290-017	CELECOXIB	CELECOXIB	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
60290-017	CELECOXIB	CELECOXIB	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
60290-018	CELECOXIB	CELECOXIB	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
60290-018	CELECOXIB	CELECOXIB	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
60290-019	CELECOXIB	CELECOXIB	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
60290-019	CELECOXIB	CELECOXIB	UMEDICA LABORATORIES PRIVATE LIMITED	ANDA	Current
68071-2626	CELECOXIB	CELECOXIB	NuCare Pharmaceuticals,Inc.	ANDA	Current
70518-3292	CELECOXIB	CELECOXIB	REMEDYREPACK INC.	ANDA	Current
70518-3292	CELECOXIB	CELECOXIB	REMEDYREPACK INC.	ANDA	Current
70518-3424	CELECOXIB	CELECOXIB	REMEDYREPACK INC.	ANDA	Current
71335-2019	CELECOXIB	CELECOXIB	Bryant Ranch Prepack	ANDA	Current
71335-2019	CELECOXIB	CELECOXIB	Bryant Ranch Prepack	ANDA	Current
75834-236	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-236	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-236	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-236	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-236	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-236	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-237	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-237	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-237	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-237	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-237	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-237	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-238	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-238	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-238	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-238	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-238	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-238	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-239	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-239	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-239	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-239	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-239	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current
75834-239	CELECOXIB	CELECOXIB	NIVAGEN PHARMACEUTICALS, INC.	ANDA	Current