FDA.reportPublic FDA data

Application 072300

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL800MGNoNo

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 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENAmneal Pharmaceuticals LLC17577b3b-e755-45d1-8b53-775d058578b22026-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENAmazon.com Services LLCb5a47efe-222f-4cbd-b649-caafd16a08292026-07-29WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENHarris Teeter637210f0-6494-4656-8b2b-14d7476cb1272026-07-29WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENHarris Teeter9d5c994a-8363-4ddb-956c-e12b79a32a582026-07-29WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENHarris Teeter87ffbf01-54de-45a8-b2a3-367d219278822026-07-29WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENHarris Teeter14515409-736f-4119-b6a0-cb19ee2e948e2026-07-29WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENHarris Teeter1fa28cb4-ae7b-4fa9-ae64-9bd8ccfcc6332026-07-29WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ADVIL MIGRAINEIBUPROFENHaleon US Holdings LLCe4a6219d-4ad4-0119-4cf8-7fc39b4b59792026-07-29WarningsName fallback
generic name: IBUPROFEN
AdvilIBUPROFENHaleon US Holdings LLC1f01c10a-9434-91a4-2ee4-352315a6b6102026-07-29WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENH E B21567c0f-abba-4a40-a0b9-5ce49b3d96482026-07-28WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.656658cc-8cf0-42b6-af4f-4e3ab76486252026-07-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENREMEDYREPACK INC.a7756b22-73cf-4262-aa8e-0577ddecd03b2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENShield Pharmaceuticals Corp1ca722bb-940e-4b3e-9561-d87e2feb1ff82026-07-24WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENShield Pharmaceuticals Corpfc6c29b4-f1b3-4cfe-8c96-564d083be39c2026-07-24WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
childrens ibuprofenIBUPROFENRite Aid Corporation26bccfc1-bc8d-4241-a078-c760048951c92026-07-24WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENHF Acquisition Co LLC, DBA HealthFirst574b6f15-70bc-fca7-e063-6294a90a04552026-07-23WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENSafeway, Inc.a530d43d-e9c4-4edb-af66-c92860e46f452026-07-23WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENTWIN MED LLCf03958f8-aeae-edf0-e053-2a95a90a3e9e2026-07-22WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Good Sense ibuprofenIBUPROFENL. Perrigo Companyaebae4b3-18c8-4ecf-b578-1fe7cc50076b2026-07-22WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.d3a7ebef-f7ab-4b34-b62e-278a8deabf782026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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