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 3 of 7 · 135 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
celecoxibCELECOXIBPreferred Pharmaceuticals, Inc.2fc74af6-4573-411d-9082-f3edd44a52a42026-03-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAdvanced Rx Pharmacy of Tennessee, LLCeca923da-59fa-da2e-e053-2a95a90a6a512026-03-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBPreferred Pharmaceutical Inc.7f20976d-bed3-4a06-9aaf-f5b5240e4ce32026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBBryant Ranch Prepack47be1d99-eebb-42f9-80d9-291a024b13642026-03-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBAvet Pharmaceuticals Inc.4bc96d0c-b484-3cee-e063-6294a90a91932026-03-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBScieGen Pharmaceuticals, Inc.8709cbe7-3de1-4908-a0a9-53002bcee15b2026-03-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBDirect Rxac87b4f9-3f66-8cf7-e053-2995a90ade0f2026-03-06Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBSportpharm LLC528a6f12-9878-4005-8fc2-5997adbb287f2026-02-28Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
celecoxibCELECOXIBSportpharm LLC1ae11faa-5bbe-49b7-a4dd-b573c304cf662026-02-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBUmedica Laboratories USA Inc.b0e0243e-59b3-4f73-8c21-86b60fc7894b2026-01-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBQingdao BAHEAL Pharmaceutical Co., Ltd.87c16a33-5eb0-40b0-a020-ed924326f6972026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBNIVAGEN PHARMACEUTICALS, INC.ae7943ab-b1fc-f08f-e053-2995a90a051e2026-01-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBNorthwind Health Company, LLCf874eddf-b2f3-6830-e053-6394a90ade7a2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBNorthwind Health Company, LLCf2a0db9f-174b-1603-e053-2995a90a79a32026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
celecoxibCELECOXIBNorthwind Health Company, LLCc213e224-c2fb-726e-e053-2a95a90a21c52026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBNorthwind Health Company, LLCdabfb290-0a7f-3429-e053-2a95a90ae04c2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CELECOXIBCELECOXIBNorthwind Health Company, LLCdac05189-4acf-d6bb-e053-2a95a90a46a92026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBRedPharm Drug2fbaa580-f33a-417d-e063-6294a90ad7df2025-12-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBYiling Pharmaceutical, Inc.43979279-867b-4303-8f30-fc58ae75a0692025-12-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: CELECOXIB
CelecoxibCELECOXIBChartwell RX, LLCa99a67f3-ccaa-4d54-8922-d6dd30fba2742025-12-10Boxed 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