Application 213127

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CELECOXIB	CELECOXIB	CAPSULE;ORAL	100MG	No	No
002	CELECOXIB	CELECOXIB	CAPSULE;ORAL	200MG	No	No
003	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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A213127-001	CELECOXIB	CELECOXIB	100MG	CAPSULE / ORAL	2025-04-29
A213127-002	CELECOXIB	CELECOXIB	200MG	CAPSULE / ORAL	2025-04-29
A213127-003	CELECOXIB	CELECOXIB	400MG	CAPSULE / ORAL	2025-04-29

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A213127-001	CELECOXIB	100MG	CAPSULE / ORAL	2025-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213127-002	CELECOXIB	200MG	CAPSULE / ORAL	2025-04-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A213127-003	CELECOXIB	400MG	CAPSULE / ORAL	2025-04-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213127-001	CELECOXIB	100MG	CAPSULE / ORAL	2025-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213127-002	CELECOXIB	200MG	CAPSULE / ORAL	2025-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A213127-003	CELECOXIB	400MG	CAPSULE / ORAL	2025-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213127-001	CELECOXIB	100MG	CAPSULE / ORAL	2025-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213127-002	CELECOXIB	200MG	CAPSULE / ORAL	2025-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213127-003	CELECOXIB	400MG	CAPSULE / ORAL	2025-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213127-001	CELECOXIB	100MG	CAPSULE / ORAL	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213127-002	CELECOXIB	200MG	CAPSULE / ORAL	2025-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213127-003	CELECOXIB	400MG	CAPSULE / ORAL	2025-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213127-001	CELECOXIB	100MG	CAPSULE / ORAL	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213127-002	CELECOXIB	200MG	CAPSULE / ORAL	2025-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213127-003	CELECOXIB	400MG	CAPSULE / ORAL	2025-04-29	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213127-001	CELECOXIB	100MG	CAPSULE / ORAL	2025-04-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213127-002	CELECOXIB	200MG	CAPSULE / ORAL	2025-04-29	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213127-003	CELECOXIB	400MG	CAPSULE / ORAL	2025-04-29	`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 5 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	550c828b-8c88-4c47-a7b8-a436aed46dc7	2025-01-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
CELECOXIB	CELECOXIB	Bryant Ranch Prepack	deeecba5-7a76-444b-a891-b00b1fb16d51	2025-01-29	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: CELECOXIB generic name: CELECOXIB
Celecoxib	CELECOXIB	EPIC PHARMA, LLC	ac670924-0a3f-4f94-ac01-9e3c3071c990	2025-01-07	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Cranbury Pharmaceuticals, LLC	933532fa-044a-48b1-bbe4-28062564f98a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	af73fea0-5cd1-0fa2-e053-2a95a90af8fc	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	af9d962a-5469-2039-e053-2a95a90ad59f	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	af9da1f2-717b-32b6-e053-2995a90ae585	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx of Tennessee, LLC	b3545cfb-97c3-b896-e053-2a95a90a15a0	2024-12-31	Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	c8ade384-2072-2cc2-e053-2a95a90ae791	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	c1abc73e-c6ab-a0a5-e053-2a95a90a0817	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f60394f5-fd69-929b-e053-2995a90a5793	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f8fdcc56-7a53-9a42-e053-6394a90a48d5	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Advanced Rx Pharmacy of Tennessee, LLC	f8fdd580-09da-9c1c-e053-6394a90a4706	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Modavar Pharmaceuticals LLC	b0f73074-f3d8-4812-8e64-f88a02869ed3	2024-12-27	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Torrent Pharmaceuticals Limited	862698b6-2cc9-4374-992d-024beae6eba3	2024-12-23	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Quality Care Products, LLC	fcf49d7f-8319-4051-b7ac-fe063268b39b	2024-12-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Unichem Pharmaceuticals (USA), Inc.	0e8484a8-04a6-4be3-8c5c-1883b0490d53	2024-12-18	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
celecoxib	CELECOXIB	Quality Care Products LLC	f0df546e-17c9-4e85-839d-336612d7b9e5	2024-12-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Bryant Ranch Prepack	0d89c39e-4858-4255-9127-1366e005203c	2024-12-11	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Celecoxib generic name: CELECOXIB
Celecoxib	CELECOXIB	Bryant Ranch Prepack	0dc9020d-28f5-4c69-896c-87b38e3ddb88	2024-12-11	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.