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 6 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
CELECOXIB	CELECOXIB	Proficient Rx LP	1071fcb5-0e9f-4e30-8fb4-df76fd876fe8	2024-09-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	A-S Medication Solutions	85b87dd2-c609-4d69-99eb-0acd852acdaf	2024-08-21	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	627abea5-e39a-4e4f-b1ab-4842ed8112e9	2024-08-15	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	NuCare Pharmaceuticals,Inc.	dfdc74e8-1e4e-53e1-e053-2995a90abc52	2024-08-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	NuCare Pharmaceuticals, Inc.	1cbe21c0-3425-9a25-e063-6294a90a0d1d	2024-07-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	NuCare Pharmaceuticals,Inc.	69aebbab-9906-be86-e053-2991aa0aa8a5	2024-06-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Asclemed USA, Inc.	265b50cc-6d99-4ef8-8439-6792e1f21c68	2024-05-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	15d6ef4f-568d-9d3e-e063-6294a90ab04c	2024-04-10	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Medsource Pharmaceuticals	14962aef-7609-b29a-e063-6394a90a5399	2024-03-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Bryant Ranch Prepack	631154cd-8f61-41b2-a686-80edc711cdaa	2024-02-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Lupin Pharmaceuticals, Inc.	560017b1-daf8-464e-b86f-0a75c78002ec	2023-12-08	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Proficient Rx LP	c529b321-38ed-434f-b76e-06902cdd40dc	2023-12-01	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 · 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