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 9 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENST. MARY'S MEDICAL PARK PHARMACY88dda062-2b9c-3632-e053-2a95a90a14312026-05-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.bdc3f482-6fba-4420-9118-0f5cb7744e972026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals, Inc.72ec2491-924d-460f-9510-62d624d54b592026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.60c731c6-4dc4-490a-8469-0b7e58e563a12026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.13fd4401-1821-4f2b-a44e-96aa2fa75b5c2026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
good sense ibuprofenIBUPROFENPreferred Pharmaceuticals Inc.f1a03b1f-2d87-43cc-b256-bd296ccd09f22026-05-13WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.25d9f5fc-4d95-4018-add8-ba696b6079b22026-05-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Motrin InfantsIBUPROFENKenvue Brands LLCc57f6ded-c0bd-45ae-823a-4c02ce334d982026-05-12WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENQPharma Incfd8b82a7-96fe-8bf5-e053-6394a90a39352026-05-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen minisIBUPROFENCVS Pharmacya6fc144a-6826-4bf7-8efb-8cdb896387f12026-05-12WarningsName fallback
generic name: IBUPROFEN
Good Sense Infants IbuprofenIBUPROFENL. Perrigo Company3d2fa7ad-1574-4c79-959d-3ee284468a992026-05-11WarningsName fallback
generic name: IBUPROFEN
Childrens Ibuprofen Oral Suspension Dye freeIBUPROFENAptaPharma Inc.bb995c57-a2cc-4bc7-9c7d-f885c425be642026-05-10WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.05ce8e8e-0b25-061e-e063-6394a90a2e922026-05-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofen infantsIBUPROFENH E Be353bc69-c03e-4bae-a357-f7f3fab916952026-05-07WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENGranules Pharmaceuticals Inc.4aefcb3a-5dc8-b88e-e063-6294a90ac0442026-05-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENH E B4805977f-a30b-4f86-9ef5-e66ad6b8bd532026-05-06WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE4a0c744f-4ad8-445e-bab1-7ffee35bf8612026-05-06WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
infants dye free ibuprofenIBUPROFENKroger Company6dc009c8-5b44-4d53-b053-eaed2223d9752026-05-05WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENKroger Company6307485a-8be6-40ee-899b-00eb3ee8ce612026-05-01WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENSt. Mary's Medical Park Pharmacy95830141-2439-9d45-e053-2995a90ae0842026-05-01Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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