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 24 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENChain Drug Consortium6c593a9c-680e-4645-8e8f-d8d044c92ca12025-07-18WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
topcare childrens ibuprofenIBUPROFENTopco Associates LLCa88020c0-7982-4307-9836-74de66ea47a52025-07-17WarningsName fallback
generic name: IBUPROFEN
profen ib infantsIBUPROFENPublix Super Markets Inc84aea3fc-4f3b-4a76-a3a6-94ed6549dbea2025-07-17WarningsName fallback
generic name: IBUPROFEN
childrens ibuprofenIBUPROFENMeijer Distribution Inccfe27d2a-b602-4b3e-bdcb-14fed4a236ca2025-07-17WarningsName fallback
generic name: IBUPROFEN
Dg Health IbuprofenIBUPROFENDolgencorp, LLC9022e393-084e-499b-ac84-f35360d795922025-07-17WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENDemoulas Super Markets, Inc39802e26-1028-d2fe-e063-6394a90a24c72025-07-16WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAMERIFOODS TRADING COMPANYf6dc62db-f728-66fc-e053-6394a90a96b32025-07-15WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENMARC GLASSMAN, INC.7f366669-9d31-46c7-932d-02fa64b11f302025-07-15WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENMarc Glassman, Inc.9714e804-fadb-103d-e053-2a95a90ad7652025-07-15WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENAMERIFOODS TRADING COMPANYf6dc2a73-046b-6b93-e053-6294a90ab2952025-07-15WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENMARC GLASSMAN, INC.9714de6b-068b-d6b9-e053-2995a90a3b272025-07-15WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENKroger Company91da5b64-db7f-4954-89e8-977b31247f9c2025-07-11WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENRite Aid Corporation70eb40b8-5862-4eb9-adc8-8a9d6bca7c7d2025-07-11WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENSafeway0fe94b11-f7c9-4e32-976f-e5f11d01bd642025-07-09WarningsName fallback
generic name: IBUPROFEN
Foster and Thrive IbuprofenIBUPROFENStrategic Sourcing Services LLCcf330b44-2d69-4f9f-99eb-2caa80aca8732025-07-08WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.6cf3328b-da8f-4f6b-8237-16a4d6b9c8332025-07-07WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.f4dad3d6-1366-4bdf-99eb-370ab74a6b9e2025-07-07WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.398fbd9c-3a7f-4210-bedb-dfe2e7cbc43e2025-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUIBUPROFENDr. Reddy's Laboratories Limited24731405-219c-79b4-ecf0-7d5fbfda94ba2025-07-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: IBUPROFEN
ibuprofen 200IBUPROFENWalgreen Company49a3d51d-55d1-4b80-ab7b-35c27a937cb92025-07-02WarningsName 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