Application 213301

Type: ANDA
Sponsor: UNICHEM

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 45.

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
A213301-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12
A213301-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12
A213301-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12
A213301-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12

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 · 156 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-11-14 07:37:17	2026-10	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`d4dbc9d85df4…`
2026-11-14 07:37:17	2026-10	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`d4dbc9d85df4…`
2026-10-15 13:18:30	2026-09	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`03ed91905a0d…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-03-09 01:35 UTC	2022-03	A213301-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213301-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213301-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A213301-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213301-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213301-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213301-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A213301-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213301-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213301-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213301-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213301-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213301-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213301-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213301-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A213301-004	AB	1	`5aa47cf7b7d7…`

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 3 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	47be1d99-eebb-42f9-80d9-291a024b1364	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	Avet Pharmaceuticals Inc.	4bc96d0c-b484-3cee-e063-6294a90a9193	2026-03-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	ScieGen Pharmaceuticals, Inc.	8709cbe7-3de1-4908-a0a9-53002bcee15b	2026-03-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	Direct Rx	ac87b4f9-3f66-8cf7-e053-2995a90ade0f	2026-03-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	Sportpharm LLC	528a6f12-9878-4005-8fc2-5997adbb287f	2026-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Sportpharm LLC	1ae11faa-5bbe-49b7-a4dd-b573c304cf66	2026-02-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	Qingdao BAHEAL Pharmaceutical Co., Ltd.	87c16a33-5eb0-40b0-a020-ed924326f697	2026-01-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	f874eddf-b2f3-6830-e053-6394a90ade7a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	f2a0db9f-174b-1603-e053-2995a90a79a3	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
celecoxib	CELECOXIB	Northwind Health Company, LLC	c213e224-c2fb-726e-e053-2a95a90a21c5	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	dabfb290-0a7f-3429-e053-2a95a90ae04c	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
CELECOXIB	CELECOXIB	Northwind Health Company, LLC	dac05189-4acf-d6bb-e053-2a95a90a46a9	2026-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	RedPharm Drug	2fbaa580-f33a-417d-e063-6294a90ad7df	2025-12-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Yiling Pharmaceutical, Inc.	43979279-867b-4303-8f30-fc58ae75a069	2025-12-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Chartwell RX, LLC	a99a67f3-ccaa-4d54-8922-d6dd30fba274	2025-12-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
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

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-157	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-157	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-157	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-158	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-158	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-158	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-373	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-373	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-373	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-374	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-374	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-374	Celecoxib	Celecoxib	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current