FDA.reportPublic FDA data

Application 071267

Type
ANDA
Sponsor
CONTRACT PHARMACAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;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 42 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)759e5cf4-641f-4b3c-bc06-9ee0b4d010fc2023-03-16WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Motrin IBIBUPROFENNavajo Manufacturing Company Inc.f70c1b68-61c8-b333-e053-6294a90aadaa2023-03-16WarningsName fallback
generic name: IBUPROFEN
Advil LiquigelsIBUPROFENNavajo Manufacturing Company Inc.e2c09216-fd63-4d50-9878-62b36236b2e72023-03-15WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.a3fadcc0-97f5-9f9b-e053-2a95a90aeb542023-03-15WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENCardinal Health (Leader) 70000e751cb66-5fa5-4171-b061-da34aa10de6c2023-03-10WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen minisIBUPROFENEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)c3f1b721-2bb0-4297-bfc6-7faaf9ba84192023-03-09WarningsName fallback
generic name: IBUPROFEN
IBUIBUPROFENProficient Rx LPea6f626d-cda3-46e2-9ac9-4e72204cb7262023-03-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPLD Acquisitions LLC DBA Avma Pharma Solutions1662a495-4f6a-4515-a405-557681e1a4962023-02-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENRite Aid Corporationa35f04f8-8c7f-5e23-e053-2995a90a30ff2023-02-08WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPAKIBUPROFENPureTek Corporationa63f3857-92d1-0adf-e053-2995a90a3afa2023-01-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
Topcare IbuprofenIBUPROFENTopco Associates LLC742f33fa-8923-4415-bcd6-8db37f2e19742023-01-06WarningsName fallback
generic name: IBUPROFEN
Flex-PrinIBUPROFENProvision Medical Productsc01538b0-ca4c-434a-be8f-fe023deb84e12023-01-05WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENDOLGENCORP INC8f1358aa-495a-23da-e053-2995a90aa4302023-01-02WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENWALGREEN COMPANY4ce20d2b-2dfb-4405-b545-dd1f67b2c5882022-12-28WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Migraine ReliefIBUPROFENWALGREENS3d560acb-3334-4a39-9ab1-f131060e3b332022-12-28WarningsName fallback
generic name: IBUPROFEN
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYb9ff2469-22c7-fc70-e053-2a95a90abc492022-12-28WarningsName fallback
generic name: IBUPROFEN
Dye-Free Ibuprofen 200IBUPROFENWALGREEN COMPANYbcd15c0f-8231-296f-e053-2995a90a280c2022-12-28WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENWal-Mart Stores, Inc.9e5332ab-92bc-3a33-e053-2995a90a642d2022-12-28WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Dye-Free IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.d0eff659-6445-a56a-e053-2995a90a72e92022-12-27WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.553d16e1-928e-4919-bc53-6683a035e2b02022-12-27WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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