Application 213598

Type: ANDA
Sponsor: NANJING

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CELECOXIB	CELECOXIB	CAPSULE;ORAL	200MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213598-001	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	AB		2020-05-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A213598-001	AB

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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213598-001	CELECOXIB	200MG	CAPSULE / ORAL	AB	2020-05-13	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A213598-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213598-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213598-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213598-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213598-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213598-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213598-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213598-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213598-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213598-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213598-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213598-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213598-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213598-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213598-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213598-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213598-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213598-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213598-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213598-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213598-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213598-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213598-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213598-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213598-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213598-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213598-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213598-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213598-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213598-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213598-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213598-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213598-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213598-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213598-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213598-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213598-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213598-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213598-001	AB	1	`a50c72e98297…`

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 2 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Celecoxib	CELECOXIB	REMEDYREPACK INC.	f5d0e5b9-97d8-42a4-a0a0-c09dde7008e6	2026-06-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	78d59905-4a78-4d9f-ac29-58790a5b3a92	2026-06-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	fd569104-8243-48fa-8e93-5a08654ad6dd	2026-05-22	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	Redpharm Drug	5250529a-6a03-78a1-e063-6294a90a47f9	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	PD-Rx Pharmaceuticals, Inc.	52572bfb-43f0-4b55-b1fd-231a05c8b83e	2026-05-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	AvPAK	951df0f7-5fb7-40f5-e053-2995a90a1edd	2026-05-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Macleods Pharmaceuticals Limited	d14aecf5-16e9-459a-bda4-4ca8f290796a	2026-05-13	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	REMEDYREPACK INC.	56d64558-1fad-420e-8fcd-7103cd073127	2026-05-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	ST. MARY'S MEDICAL PARK PHARMACY	ed2093f6-1606-100a-e053-2995a90a5b95	2026-05-04	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	REMEDYREPACK INC.	56127f57-7810-4f5d-a11d-e08fb2ed138b	2026-04-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Apotex Corp.	a62612b3-9564-2b34-be59-6aa5ac53679c	2026-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Direct_Rx	4b2ffbdb-1847-d93b-e063-6394a90a06f5	2026-04-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Northwind Health Company, LLC	0de7a6f8-baba-1fd0-e063-6394a90ad434	2026-04-16	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	REMEDYREPACK INC.	d0ca85fa-8b80-4a48-a1a4-a1c181821c39	2026-04-09	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	ST. MARY'S MEDICAL PARK PHARMACY	4e57bd99-5b7a-c2c7-e063-6294a90afb8c	2026-03-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	AiPing Pharmaceutical, Inc.	89db0dec-3800-4d89-a765-24838f4d0c30	2026-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Preferred Pharmaceuticals Inc.	b0839895-6a36-4e4f-9336-98632b60622a	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Preferred Pharmaceuticals, Inc.	f2a5ffbd-49c4-4a97-867b-2b14a3675020	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Preferred Pharmaceuticals Inc.	a6000132-ac6c-4b61-a98a-8cc2dd84b3f0	2026-03-25	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Preferred Pharmaceuticals, Inc.	d35d9494-4190-41a8-80d4-c9d877c432e9	2026-03-24	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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
69680-135	Celecoxib	Celecoxib	Vitruvias Therapeutics	ANDA	Current
72567-001	Generic drug	Celecoxib	Simcere of America, Inc.	ANDA	Current
72567-001	Generic drug	Celecoxib	Simcere of America, Inc.	ANDA	Current
72567-001	Generic drug	Celecoxib	Simcere of America, Inc.	ANDA	Current