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 5 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	b3545cfb-97c3-b896-e053-2a95a90a15a0	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	c8ade384-2072-2cc2-e053-2a95a90ae791	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	c1abc73e-c6ab-a0a5-e053-2a95a90a0817	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f60394f5-fd69-929b-e053-2995a90a5793	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f8fdcc56-7a53-9a42-e053-6394a90a48d5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f8fdd580-09da-9c1c-e053-6394a90a4706	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Modavar Pharmaceuticals LLC	b0f73074-f3d8-4812-8e64-f88a02869ed3	2024-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Torrent Pharmaceuticals Limited	862698b6-2cc9-4374-992d-024beae6eba3	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Quality Care Products, LLC	fcf49d7f-8319-4051-b7ac-fe063268b39b	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Quality Care Products LLC	f0df546e-17c9-4e85-839d-336612d7b9e5	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Bryant Ranch Prepack	0d89c39e-4858-4255-9127-1366e005203c	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Bryant Ranch Prepack	0dc9020d-28f5-4c69-896c-87b38e3ddb88	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Aurobindo Pharma Limited	1e811c3a-5653-4617-b958-380802cc443a	2024-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Cadila Pharmaceuticals Limited	78ce3df5-07ee-43bb-9348-104a9524a032	2024-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Westminster Pharmaceuticals, LLC	cb0be640-067e-4422-9bec-d5fa07175bd0	2024-12-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
ELYXYB - celecoxib	CELECOXIB	SCILEX PHARMACEUTICALS INC.	c8a5de07-9f27-4a54-a885-8089f0307bd7	2024-11-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CELECOXIB
CELEBREX	CELECOXIB	Viatris Specialty LLC	2d6675e4-5859-4be2-8037-a20ce9f707aa	2024-11-22	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CELECOXIB
Celecoxib	CELECOXIB	Bryant Ranch Prepack	1bf407db-8bc6-4aea-8bcc-eaa4c24cb7a6	2024-11-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Bryant Ranch Prepack	8a1e9a52-4627-4098-8a11-25e92ad96023	2024-11-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	A-S Medication Solutions	217265c0-e98e-482c-8af2-f8ac0ab7a0a1	2024-09-18	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