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 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
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 4 of 4 · 148 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2023-05-13 08:27 UTC	2023-05	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213301-001	CELECOXIB	50MG	CAPSULE / ORAL	2021-01-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213301-002	CELECOXIB	100MG	CAPSULE / ORAL	2021-01-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213301-003	CELECOXIB	200MG	CAPSULE / ORAL	2021-01-12	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213301-004	CELECOXIB	400MG	CAPSULE / ORAL	2021-01-12	`a50c72e98297…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	Unichem Pharmaceuticals (USA), Inc.	0e8484a8-04a6-4be3-8c5c-1883b0490d53	2024-12-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213301 application number: ANDA213301 ndc (product): 29300-157 ndc (product): 29300-158 ndc (product): 29300-374 ndc (product): 29300-373

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