Application 078857

Type: ANDA
Sponsor: MYLAN

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
A078857-001	CELECOXIB	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30
A078857-002	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11
A078857-003	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11
A078857-004	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078857-001	CELECOXIB	50MG	CAPSULE / ORAL	2014-05-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078857-002	CELECOXIB	100MG	CAPSULE / ORAL	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078857-003	CELECOXIB	200MG	CAPSULE / ORAL	2015-02-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078857-004	CELECOXIB	400MG	CAPSULE / ORAL	2015-02-11	`5bbf6a4d5a75…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078857-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078857-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078857-003	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078857-004	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078857-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078857-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078857-003	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078857-004	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078857-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078857-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078857-003	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078857-004	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078857-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078857-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078857-003	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078857-004	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078857-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078857-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078857-003	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078857-004	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078857-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078857-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078857-003	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A078857-004	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078857-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078857-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078857-003	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078857-004	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078857-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078857-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078857-003	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A078857-004	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078857-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078857-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078857-003	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A078857-004	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078857-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078857-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078857-003	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A078857-004	AB	1	`c0c555d07b60…`

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 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
celecoxib	CELECOXIB	Asclemed USA, Inc.	2a926010-08e1-44dd-bc6d-ed15374bd0d3	2023-09-02	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	A-S Medication Solutions	00e67d5e-df6f-4dfd-8c2d-a001c8a99af0	2023-08-24	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	A-S Medication Solutions	dea035a6-dcf1-4b7d-8adc-a2f678b71fd9	2023-08-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Proficient Rx LP	b9a7f32c-8136-4f29-be6b-4d5e904ca0f1	2023-05-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
CELECOXIB	CELECOXIB	A-S Medication Solutions	c7a183dc-f4d5-483f-964c-f2745a3640ad	2023-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
celecoxib	CELECOXIB	A-S Medication Solutions	85bfe02b-bfcb-44ee-81a0-11765c3054a9	2023-02-06	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Proficient Rx LP	0ad14a4e-2f05-4ce7-93d1-1cb7e4d8f7d0	2022-08-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Proficient Rx LP	cbd2d6de-6f0d-4b69-8e27-a1fe08830ba5	2022-04-01	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Tianjin Tianyao Pharmaceuticals Co., Ltd.	76f9bcb7-0e94-485f-816d-61d4e1ed24e0	2022-02-28	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
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 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-7150	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7150	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7150	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7150	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7150	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7150	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7160	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7160	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7160	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7160	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7160	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7160	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7165	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7165	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7165	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7165	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7165	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7165	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7170	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7170	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7170	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7170	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7170	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-7170	Celecoxib	celecoxib	Mylan Pharmaceuticals Inc.	ANDA	Current
43353-257	Celecoxib	celecoxib	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current
51079-199	Celecoxib	celecoxib	Mylan Institutional Inc.	ANDA	Current
51079-199	Celecoxib	celecoxib	Mylan Institutional Inc.	ANDA	Current
51079-199	Celecoxib	celecoxib	Mylan Institutional Inc.	ANDA	Current
51079-215	Celecoxib	celecoxib	Mylan Institutional Inc.	ANDA	Current
51079-215	Celecoxib	celecoxib	Mylan Institutional Inc.	ANDA	Current
51079-215	Celecoxib	celecoxib	Mylan Institutional Inc.	ANDA	Current
60429-459	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-459	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-459	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-460	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-460	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-460	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-460	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-460	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-461	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-461	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-461	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-461	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-461	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-462	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-462	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
60429-462	Celecoxib	celecoxib	Golden State Medical Supply, Inc.	ANDA	Current
71335-0437	Celecoxib	celecoxib	Bryant Ranch Prepack	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
31392	ORIG	2014-06-02