FDA.reportPublic FDA data

Application 021156

Type
NDA
Sponsor
GD SEARLE LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CELEBREXCELECOXIBCAPSULE;ORAL100MGNoNo
002CELEBREXCELECOXIBCAPSULE;ORAL200MGNoNo
003CELEBREXCELECOXIBCAPSULE;ORAL400MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CELECOXIBCELECOXIBBryant Ranch Prepack550c828b-8c88-4c47-a7b8-a436aed46dc72025-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBBryant Ranch Prepackdeeecba5-7a76-444b-a891-b00b1fb16d512025-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBEPIC PHARMA, LLCac670924-0a3f-4f94-ac01-9e3c3071c9902025-01-07Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBCranbury Pharmaceuticals, LLC933532fa-044a-48b1-bbe4-28062564f98a2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf73fea0-5cd1-0fa2-e053-2a95a90af8fc2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9d962a-5469-2039-e053-2a95a90ad59f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCaf9da1f2-717b-32b6-e053-2995a90ae5852024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx of Tennessee, LLCb3545cfb-97c3-b896-e053-2a95a90a15a02024-12-31Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCc8ade384-2072-2cc2-e053-2a95a90ae7912024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCc1abc73e-c6ab-a0a5-e053-2a95a90a08172024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf60394f5-fd69-929b-e053-2995a90a57932024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf8fdcc56-7a53-9a42-e053-6394a90a48d52024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCf8fdd580-09da-9c1c-e053-6394a90a47062024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBModavar Pharmaceuticals LLCb0f73074-f3d8-4812-8e64-f88a02869ed32024-12-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
celecoxibCELECOXIBTorrent Pharmaceuticals Limited862698b6-2cc9-4374-992d-024beae6eba32024-12-23Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBQuality Care Products, LLCfcf49d7f-8319-4051-b7ac-fe063268b39b2024-12-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBUnichem Pharmaceuticals (USA), Inc.0e8484a8-04a6-4be3-8c5c-1883b0490d532024-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
celecoxibCELECOXIBQuality Care Products LLCf0df546e-17c9-4e85-839d-336612d7b9e52024-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBBryant Ranch Prepack0d89c39e-4858-4255-9127-1366e005203c2024-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBBryant Ranch Prepack0dc9020d-28f5-4c69-896c-87b38e3ddb882024-12-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
36232SUPPL2011-02-09
23229SUPPL2011-02-09
4496SUPPL2011-02-09
21482ORIG2004-05-28
23629ORIG2003-12-09
26928SUPPL2002-08-29
4495SUPPL2002-08-29
36231ORIG1999-12-23
4494ORIG1999-12-23