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 7 of 7 · 126 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Aphena Pharma Solutions - Tennessee, LLC	d258e065-e9a6-44e2-89c9-6892d771d9d3	2021-08-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	Proficient Rx LP	c91e5933-1798-4096-9f08-fb1200e154e1	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	Proficient Rx LP	6dd743d3-4821-4919-90eb-6d306ca7999f	2021-01-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib 200 mg	CELECOXIB	Proficient Rx LP	feee6a01-63f9-42c3-8bd8-ca713a08b36d	2019-11-01	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: CELECOXIB
Celecoxib	CELECOXIB	Proficient Rx LP	7a234c0c-30a7-49f5-92a1-a1fc836ff9ae	2019-10-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Proficient Rx LP	c787b0ab-77ab-4f7e-9fea-be2a0085020a	2019-10-01	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