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 28 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Childrens IbuprofenIBUPROFENL. Perrigo Companya8fc1b0c-dd69-4567-8eea-de4d9b0c77402025-05-07WarningsName fallback
generic name: IBUPROFEN
foster and thrive childrens ibuprofen ibIBUPROFENStrategic Sourcing Services LLC37adf659-9a92-428b-ac99-5718f242a4e92025-05-07WarningsName fallback
generic name: IBUPROFEN
up and up ibuprofenIBUPROFENTarget Corporation6e0330ac-a111-4574-9197-d7aab33b86082025-05-07WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENMeijer Distribution Inc66b19ed1-6cf9-4705-82cd-02f23c6379e72025-05-06WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
equaline ibuprofen childrensIBUPROFENUnited Natural Foods, Inc. dba UNFI835c3bc8-fb55-4b7e-98ad-3d84d089c8cb2025-05-06WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC34673d3b-41cd-f4c9-e063-6394a90a85102025-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC3467b45b-c432-2923-e063-6394a90a10442025-05-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
ibuprofenIBUPROFENMajor Pharmaceuticalsb4962985-47e6-4389-874f-76742b086e2f2025-05-03WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
Topcare Infants IbuprofenIBUPROFENTopco Associates LLC00d33273-e8c7-4d40-8e6f-a980f746fff22025-05-03WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3732defa-67c2-4b84-8a84-4bbc27b6cb242025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.689dbbe8-4f85-48fe-8efc-fda81b60d37f2025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.09621787-9a5c-4abf-9ccd-d6f8d581738f2025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.42b92fd7-468c-4fb8-9ff0-31296735df4c2025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.7942cc53-1268-4e5f-8db0-f0b3524bb7442025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENProficient Rx LPc5eaa3a9-5aa8-46b0-8cec-639bfb3274752025-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
profen ibIBUPROFENPublix Super Markets Incbee4b754-c476-4d0e-a1b4-4db8861af84a2025-05-01WarningsName fallback
generic name: IBUPROFEN
Dye Free Childrens IbuprofenIBUPROFENCVS2cf2a4de-29d3-8af5-e063-6294a90a9cee2025-05-01WarningsName fallback
generic name: IBUPROFEN
good sense ibuprofen childrensIBUPROFENL. Perrigo Company6127469c-143f-4dd2-bd37-6630291fcd5a2025-04-30WarningsName fallback
generic name: IBUPROFEN
ibuprofen childrensIBUPROFENCVS Pharmacy4459298c-e0bf-4a10-b68c-6f83fefde7e92025-04-29WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENH E Bbbcfea51-4c57-4a2c-a0ac-2a189c5ff38a2025-04-28WarningsName 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