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 35 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUIBUPROFENNuCare Pharmaceuticals,Inc.593d9870-0213-75e6-e053-2991aa0a0eff2024-08-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
IBUIBUPROFENNuCare Pharmaceuticals Inc.575c275c-3e1a-0572-e053-2991aa0adabd2024-08-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENGranules India Limitedfd01353d-1d1d-42b5-9a03-575052189bf52024-08-13WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENFlorida Pharmaceutical Products, LLCc1733fdb-5eed-2094-e053-2995a90a6c8e2024-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepack60f1c099-5fb5-47e8-b228-11de1ef40f4b2024-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBryant Ranch Prepackffc953f7-ed92-4528-bb2f-72c634c119fa2024-08-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC19b06eaf-0d4c-2b4d-e063-6294a90a2eb92024-08-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENP & L Development, LLC6d1c9a64-c83c-4b3d-9245-704b94cb367c2024-07-30WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLCfaebc392-0fd9-4c71-8471-beba10dda0222024-07-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENActavis Pharma, Inc.3d156d13-25d8-4cfc-8285-5f7ebf48cf452024-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUIBUPROFENNuCare Pharmaceuticals,Inc.678e2d16-33f3-67a7-e053-2991aa0a11322024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC75d963b9-3675-44ff-bc6b-83461bed1b672024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC57cdd1df-a303-4265-a2d6-1d0b87105a282024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC8df77ead-27eb-4f6f-95a9-f68d3e9cfa712024-07-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.54b25106-5580-119d-e054-00144ff88e882024-07-17Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
ibuprofenIBUPROFENBryant Ranch Prepack22cb2ccc-ba4d-4069-8334-f886f0e3e8022024-07-12WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
Foster and Thrive Infants IbuprofenIBUPROFENStrategic Sourcing Services LLCfe3092af-9a7b-4189-af89-31be8d6fed532024-07-12WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.92efad86-31ae-78e5-e053-2995a90a0fda2024-07-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.3e3848f2-4922-39ea-e054-00144ff88e882024-06-25WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.999aa615-72b2-9296-e053-2a95a90ac70b2024-06-20Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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