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 10 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen Dye FreeIBUPROFENCVS Pharmacy00653b7c-7099-487e-9a01-e89781c213232026-04-29WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENCoupler LLC50766a3d-1a22-be14-e063-6294a90a0ed22026-04-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENMeijer Distribution Inc36f7227d-f3cb-44b7-a4c1-27611cd150522026-04-24WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Medique at Home IprinIBUPROFENSportpharm LLC954d0436-b681-4bf5-80ec-0de9ddcab9942026-04-24WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENCostco Wholesaleb4fa56d3-f4be-45b2-a3ac-40fe8d8bea072026-04-20WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
care one ibuprofenIBUPROFENAmerican Sales Companyd26d2766-6d4c-462b-ae8b-ef8d87acd6332026-04-16WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENCardinal Health 107, LLC9291857c-30b3-414b-99e1-9c127e72c0d42026-04-16WarningsName fallback
generic name: IBUPROFEN
Ibuprofen childrensIBUPROFENHyVee Inc55f8def6-f7de-4b3e-a92a-5cd9e68a46a12026-04-15WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENST. MARY'S MEDICAL PARK PHARMACY4e67aef4-c3ac-232a-e063-6394a90a3a852026-04-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUIBUPROFENGolden State Medical Supply, Inc.bbf4821d-f9fc-9f6e-e053-2a95a90a52532026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
Good Sense ibuprofen infantsIBUPROFENL. Perrigo Companyc79e65e7-149b-450f-b083-99e16ff717292026-04-14WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack886c974c-0d32-4a1b-8f54-40c2c12efa452026-04-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
CHILDRENS IbuprofenIBUPROFENKesin Pharma Corporation436c0126-4ff3-c082-e063-6294a90a3d722026-04-13WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENCOSTCO WHOLESALE CORPORATIONa50abf26-d6e5-10e4-ea90-a40b96a887e52026-04-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofen childrensIBUPROFENHyVee Inc3d8497c6-1c46-4248-b75c-b086591529cc2026-04-10WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENRite Aid Corporation72e11f2d-a348-4c12-9cd8-1e6f0f6f73992026-04-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
care one ibuprofenIBUPROFENAmerican Sales Company15f63d40-276c-4c02-9f8c-0354e47799162026-04-09WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENREMEDYREPACK INC.a348a959-46bc-4ff6-8936-12866fc34a4b2026-04-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
AdvilIBUPROFENNavajo Manufacturing Company Inc.4a64522f-b7d8-47f7-bf07-c9e8f10864252026-04-08WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENDiscount Drug Martcffad7af-44f5-4e54-9e46-c3c5d4ca182f2026-04-08WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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