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 43.

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 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207061-001	CELECOXIB	50MG	CAPSULE / ORAL	2017-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207061-002	CELECOXIB	100MG	CAPSULE / ORAL	2017-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207061-003	CELECOXIB	200MG	CAPSULE / ORAL	2017-04-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207061-004	CELECOXIB	400MG	CAPSULE / ORAL	2017-04-04	`caaa826d4ba7…`
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…`

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 · 139 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Major Pharmaceuticals	3a1eadd5-c0a7-473e-bde0-6b9450d11c95	2026-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	REMEDYREPACK INC.	c96509cc-47f4-44f8-9f7e-4e49cc3d5348	2026-08-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	DirectRx	e0f3aacf-df5d-dad7-e053-2995a90ac5eb	2026-08-27	Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	A-S Medication Solutions	e84d67c8-010d-495c-8691-ae16d0698f8d	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	St. Mary's Medical Park Pharmacy	59f495e8-3cea-9d98-e063-6394a90a89d4	2026-08-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Direct_Rx	59cca611-c035-da50-e063-6294a90a73f5	2026-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Mullan Pharmaceutical Inc.	643e177f-216d-4dfa-824a-7516a488304e	2026-08-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	REMEDYREPACK INC.	b3acbfd9-a1c2-4aa6-b5f0-013cfad6cca8	2026-08-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	REMEDYREPACK INC.	e18d2fa4-4982-4e2a-af55-4319d6416efb	2026-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	American Health Packaging	4af52ae3-6b9d-4bc9-ad6b-c983e4c9dcc7	2026-08-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	A-S Medication Solutions	d799328f-9ea0-4b64-9667-8feaa97f150c	2026-08-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	b06ced10-81c6-4f48-a205-1e0db228cb8b	2026-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Alembic Pharmaceuticals Inc.	806e5f8a-f986-4f88-ba3e-8265f86afa48	2026-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
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	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

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