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 4 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Alembic Pharmaceuticals Limited	14e8d788-e44c-4a40-8678-25cf45fed477	2025-09-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	PHOENIX RX LLC	3a669c28-fbc7-827c-e063-6394a90a0829	2025-08-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
VYSCOXA	CELECOXIB	Carwin Pharmaceutical Associates, LLC	5094d47e-f791-4190-9397-b7500143a74d	2025-07-31	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CELECOXIB
Celecoxib	CELECOXIB	PHOENIX RX LLC	3a7b127e-c919-418f-e063-6394a90a06d0	2025-07-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Proficient Rx LP	3a450db8-313c-4120-9b8e-58c956323fa4	2025-06-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	A-S Medication Solutions	95b2ced1-eca2-4c25-aa10-c9fb86b353a3	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
CELECOXIB	CELECOXIB	A-S Medication Solutions	7b8e923c-253f-461e-94d7-669e75dc73e9	2025-05-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
celecoxib	CELECOXIB	Bryant Ranch Prepack	351f5f07-bdd4-9893-e063-6394a90a7281	2025-05-14	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	Micro Labs Limited	408b30d6-f5c2-4239-b993-d8f77a8e160b	2025-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	Actavis Pharma, Inc.	05224473-27dc-4f6d-a52a-c40a7af2f2f4	2025-04-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Asclemed USA, Inc.	5d0dcac1-237c-47aa-bcfb-50fa20b5b838	2025-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	3191c9dc-bfdf-0591-e054-00144ff8d46c	2025-04-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
celecoxib	CELECOXIB	RedPharm Drug, Inc.	50c29846-3426-0310-e054-00144ff8d46c	2025-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Asclemed USA, Inc.	f6291230-7598-407a-aef0-ec1f09277d2a	2025-03-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	Quallent Pharmaceuticals Health LLC	aaa3a4f5-b281-415f-a08c-e0cefdae2fb5	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
CELECOXIB	CELECOXIB	Cipla USA Inc.	d12625b1-2af9-4532-af91-d40b65eeffef	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
CELECOXIB	CELECOXIB	NorthStar RxLLC	ce61a585-5ac0-4185-99eb-a9511cd25a98	2025-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
celecoxib	CELECOXIB	Bryant Ranch Prepack	ac5c0d72-1bb3-4065-b2f4-5516b0869775	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	NCS HealthCare of KY, LLC dba Vangard Labs	34bef49c-eca1-4f17-9b1b-55900ac40829	2025-02-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Bryant Ranch Prepack	a9749f00-0307-4842-a95b-9a8b4989df25	2025-02-03	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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