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 33 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENH E Ba340ed68-debb-4c1e-97eb-82f6e9e3854f2024-12-02WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
365 whole foods market ibuprofenIBUPROFENWhole Foods Market, INC.e914472b-c785-4c73-b37c-4d459166cf412024-11-26WarningsName fallback
generic name: IBUPROFEN
INFANTS ADVILIBUPROFENHaleon US Holdings LLCdb5ed801-7a7e-3c83-0172-77f914daaa5a2024-11-26WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC1ef5693b-d00a-28fb-e063-6294a90a7ede2024-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENTIME CAP LABORATORIES, INCec3e8443-d742-4c25-8516-f0df4ebfccdc2024-11-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
dg health ibuprofenIBUPROFENDolgencorp, LLCfd27d4e1-8edf-4bc3-a593-6be5c3345ed02024-11-13WarningsName fallback
generic name: IBUPROFEN
Childrens MotrinIBUPROFENKenvue Brands LLC4f664479-f68c-464a-956d-25bb9f39c4cc2024-11-08WarningsName fallback
generic name: IBUPROFEN
Childrens MotrinIBUPROFENKenvue Brands LLC152189e5-391c-42d3-a03b-c8364e2de6bf2024-11-08WarningsName fallback
generic name: IBUPROFEN
good sense ibuprofenIBUPROFENA-S Medication Solutions9ac095d2-ba19-4da1-acc9-85f7b4ae304d2024-11-04WarningsName fallback
generic name: IBUPROFEN
Childrens MotrinIBUPROFENKenvue Brands LLC9e1cdef7-921f-4163-869c-6c062e31c5bb2024-11-01WarningsName fallback
generic name: IBUPROFEN
Childrens MOTRINIBUPROFENKenvue Brands LLCf2609308-17bf-4bcb-84b2-d17f3fd359582024-11-01WarningsName fallback
generic name: IBUPROFEN
GOOD REMEDIES ibuprofen 200 mgIBUPROFENStrive Pharmaceuticals Inc.24fb3741-65e0-898d-e063-6394a90af5692024-10-31WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack7650f84b-92f2-4065-8ef2-f5de5bd7002b2024-10-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack1361b6d6-0443-460a-8446-41f63a1e28df2024-10-28Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENRugby Laboratories, Inc.05c4e6c7-bf95-4e05-b7da-7a8778de342b2024-10-28WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb619068-be71-7569-e053-2a95a90a4a6e2024-10-26WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen Pain Reliever/Fever ReducerIBUPROFENAmneal Pharmaceuticals LLC877440fc-3afb-4123-a2e6-5cb48c74413c2024-10-25WarningsName fallback
generic name: IBUPROFEN
Ibuprofen Pain Reliever/Fever ReducerIBUPROFENAmneal Pharmaceuticals LLC5f27dd3f-c735-417b-95e6-26dc5aae5a7a2024-10-25WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutions2d0c2d35-c212-4daa-b2c4-b407ca0b16ad2024-10-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutions2b470e48-c23c-4f5c-916a-d38d8518896b2024-10-21Boxed 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.