Application 207061

Type: ANDA
Sponsor: JUBILANT GENERICS

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	Approval date
A207061-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04
A207061-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04
A207061-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04
A207061-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04

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 · 164 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`d06236e962d9…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A207061-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207061-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207061-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207061-004	AB	1	`74a2ff9319b5…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207061-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207061-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207061-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A207061-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A207061-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207061-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207061-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A207061-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A207061-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207061-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207061-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A207061-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A207061-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207061-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207061-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A207061-004	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A207061-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207061-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207061-003	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A207061-004	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A207061-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207061-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207061-003	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A207061-004	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A207061-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207061-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207061-003	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A207061-004	AB	1	`ea99ee380514…`

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 7 · 133 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	St. Mary's Medical Park Pharmacy	57b07096-6d7c-1653-e063-6294a90aa6e2	2026-07-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	REMEDYREPACK INC.	27f17ae7-939b-402e-9498-3b6611104089	2026-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	06076494-62ad-4f58-b8bb-7038fcfe3b12	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	American Health Packaging	4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc7	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	St. Mary's Medical Park Pharmacy	3bc74e76-0517-69c6-e063-6394a90abe75	2026-07-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Cardinal Health 107, LLC	a9114d6a-13d7-443c-be44-7866b4a4cf96	2026-07-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	HAWAII REPACK, INC.	45816eae-ad83-4d2f-a035-c3f9f24708f9	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	HAWAII REPACK, INC.	77f3b90b-a25d-4c47-975a-2a988d696a3f	2026-07-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	St Mary's Medical Park Pharmacy	e1ab644d-b668-3cf3-e053-2995a90addb0	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Radha Pharmaceuticals, Inc.	2c86ece8-1cf5-4688-91b1-8aef5d60b7e4	2026-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Bryant Ranch Prepack	d94849a7-1831-4319-982c-c6b20dc42038	2026-06-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	REMEDYREPACK INC.	f5d0e5b9-97d8-42a4-a0a0-c09dde7008e6	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	78d59905-4a78-4d9f-ac29-58790a5b3a92	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	fd569104-8243-48fa-8e93-5a08654ad6dd	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	Redpharm Drug	5250529a-6a03-78a1-e063-6294a90a47f9	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	52572bfb-43f0-4b55-b1fd-231a05c8b83e	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	AvPAK	951df0f7-5fb7-40f5-e053-2995a90a1edd	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Macleods Pharmaceuticals Limited	d14aecf5-16e9-459a-bda4-4ca8f290796a	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	REMEDYREPACK INC.	56d64558-1fad-420e-8fcd-7103cd073127	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	ST. MARY'S MEDICAL PARK PHARMACY	ed2093f6-1606-100a-e053-2995a90a5b95	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
59746-561	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-561	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-561	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-561	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-561	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-562	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-562	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-562	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-562	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-562	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-563	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-563	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-563	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-563	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-563	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-564	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-564	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-564	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-564	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current
59746-564	Celecoxib	Celecoxib	Jubilant Cadista Pharmaceuticals Inc.	ANDA	Current