FDA.reportPublic FDA data

Application 206990

Type
ANDA
Sponsor
SHANDONG XINHUA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001IBUPROFENIBUPROFENTABLET;ORAL200MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A206990-001IBUPROFEN200MGTABLET / ORAL2018-08-2174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A206990-001IBUPROFEN200MGTABLET / ORAL2018-08-213f01610625f2…
2019-09-15 20:21 UTC2019-09A206990-001IBUPROFEN200MGTABLET / ORAL2018-08-21b00525d2431f…
2019-07-19 19:46 UTC2019-07A206990-001IBUPROFEN200MGTABLET / ORAL2018-08-21ea99ee380514…

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 45 of 47 · 926 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENAphena Pharma Solutions - Tennessee, LLC77adb094-869c-44b4-8a4e-b739ac9cd7012021-04-20Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IBUIBUPROFENAphena Pharma Solutions - Tennessee, LLC3e45f971-b6f7-4ec5-9d8e-1b9127b6c0bd2021-01-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENProficient Rx LP924d2dd0-3b7d-42ec-b617-86729dba2b952021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENProficient Rx LPe23eb275-ce0c-40ec-b809-a48c5e46c7ec2021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENProficient Rx LP8813a8a4-ebbd-4204-88a3-600a92ea91702020-12-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENCVS Pharmacy60fd517d-608b-473e-8a44-eb98424599972020-10-22WarningsName fallback
generic name: IBUPROFEN
Ibuprofen IBIBUPROFENWINCO FOODS, LLC9d78644d-83c7-46d1-8156-0d76acb7c2992020-09-17WarningsName fallback
generic name: IBUPROFEN
Ibuprofen IBIBUPROFENWINCO FOODS, LLCee867519-227f-44ba-ba8b-2dbefcc9fc672020-09-17WarningsName fallback
generic name: IBUPROFEN
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLC18e5eed7-d3be-4559-93ca-b40ee26c7bd82020-09-09WarningsName fallback
generic name: IBUPROFEN
Basic Care Childrens IbuprofenIBUPROFENAmazon.com Services LLCd53cb3f1-6689-40dd-bdea-fad3a841d4822020-09-03WarningsName fallback
generic name: IBUPROFEN
Dolex ChildrenIBUPROFENPharmadel LLCac3c264f-da37-a474-e053-2a95a90abdad2020-08-06WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENBryant Ranch Prepack6d189e86-4c36-43f5-b406-a342458d41552020-05-27Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
childrens ibuprofenIBUPROFENRite Aid Corporationaf68a4bf-bc49-40c7-812d-035eff474ed92020-04-03WarningsName fallback
generic name: IBUPROFEN
JUNIOR STRENGTH ADVILIBUPROFENProficient Rx LP91fc4794-1880-460f-86dd-49d8c1e872bc2020-03-01WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENProficient Rx LP6d84ed87-b643-46e2-96d4-2052f41bd9362020-02-01WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPURACAP PHARMACEUTICAL LLC9e86b6e5-5374-4699-a0d1-a4c3d069f2622020-01-17WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
childrens ibuprofenIBUPROFENH E Be7e2b766-6d05-49e2-9e88-72454b8579352019-12-27WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC73eb763e-ce21-4cff-854f-3297f20f1f612019-12-10WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPuraCap Pharmaceutical LLC40501966-419a-4ccd-b7c9-5581cbe47a972019-12-10WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPuraCap Pharmaceutical LLCb6e14f73-1f19-4cfa-8858-136a38ee32d02019-12-10WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
11788-002IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-002IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-004IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-004IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-006IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent
11788-006IbuprofenIbuprofenAiPing Pharmaceutical, Inc.ANDACurrent