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 26 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENCVS Pharmacye655bd64-dd82-46d8-87cc-2674beaffe202025-06-16WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENMajor Pharmaceuticals03993008-7bd2-465f-b5a9-1cbc3c1fff022025-06-16WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENPublix Super Markets Inc032decc5-9f7a-4f12-8ca4-a95a79a426c62025-06-16WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
care one ibuprofen childrensIBUPROFENAmerican Sales Companyc56511fd-ff2e-40f6-91e6-fe04e563fafd2025-06-13WarningsName fallback
generic name: IBUPROFEN
profen IB childrensIBUPROFENPublix Super Markets Inc1af04e26-e32c-4c1c-bbda-2c78f2030ac62025-06-13WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENTIME CAP LABORATORIES,INCf58d35f9-e44b-417b-98ce-0766b537cd2f2025-06-12WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENMarc Glassman, Inc.47434f23-5ac9-4cb4-a963-7c8bf9e063612025-06-11WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENMarc Glassman, Inc.3b0e4ccc-cc0b-42fb-9163-7560740d95922025-06-11WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Topcare Childrens IbuprofenIBUPROFENTopco Associates LLC45255d2f-c592-4750-abb5-21647d4fbd512025-06-10WarningsName fallback
generic name: IBUPROFEN
ibuprofen childrensIBUPROFENMeijer Distribution Inc625226ef-d55b-4f93-ad1e-4fe2b07d41332025-06-10WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC37299475-e2f3-de26-e063-6394a90ad62d2025-06-09WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsab11e142-9e11-4ce4-9671-7e4fe53ffe922025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENNCS HealthCare of KY, LLC dba Vangard Labsf1842893-7a34-4f77-8231-55fb0c98b22b2025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENWALGREENS7653b33c-7489-10db-e053-2991aa0ab5082025-06-06WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
AMAZON BASIC CARE IBUPROFENIBUPROFENAmazon.com Services LLC113dd693-6abe-1a0f-e063-6394a90a167e2025-06-06WarningsName fallback
generic name: IBUPROFEN
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLC9eafb61a-43bc-4845-b45a-72c7d5ac424e2025-06-05WarningsName fallback
generic name: IBUPROFEN
Ibuprofen 200IBUPROFENWalgreen Company62e8db95-aaef-4b0e-841e-64a0339f31902025-06-04WarningsName fallback
generic name: IBUPROFEN
Good Sense Ibuprofen ChildrensIBUPROFENL. Perrigo Company321d6b3a-3dff-4334-b6ee-6ac801b9907c2025-06-03WarningsName fallback
generic name: IBUPROFEN
Leader Childrens IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader2b0c3bb1-7667-403f-99e6-13c83755b1b52025-06-03WarningsName fallback
generic name: IBUPROFEN
care one ibuprofenIBUPROFENAmerican Sales Company006adf23-21ab-4a4e-aae9-c4e5877771652025-06-03WarningsName fallback
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