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 30 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31f61d5c-a3a3-3d47-e063-6394a90afb622025-04-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6005b-492e-7936-e063-6394a90ad8012025-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6ac7a-fa3e-4dd4-e063-6294a90a29af2025-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENBryant Ranch Prepackb303b554-c457-4f2b-9931-48f30943178b2025-04-03WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENBryant Ranch Prepack87c9f15f-1196-477c-b5d2-3b875bea61d02025-04-03WarningsName fallback
generic name: IBUPROFEN
dg health ibuprofenIBUPROFENDolgencorp Inc74f46147-b4c2-4bb3-bd0a-220c0a5403a62025-04-01WarningsName fallback
generic name: IBUPROFEN
good sense ibuprofenIBUPROFENL. Perrigo Company0cb4b0ef-5cdd-4c79-8718-4fb157a2c9482025-03-29WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC3140a614-c7ae-3062-e063-6394a90ad3d72025-03-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
good sense ibuprofenIBUPROFENL. Perrigo Company3b78c004-e4fe-449c-86e9-52e8ccf127852025-03-25WarningsName fallback
generic name: IBUPROFEN
Ibuprofen minisIBUPROFENWR Group, Inc.e9dad35a-6789-42d6-97da-521db7b164962025-03-24WarningsName fallback
generic name: IBUPROFEN
basic care ibuprofenIBUPROFENAmazon.com Services LLC25bc5cc2-9b6a-47e4-8b3d-2bb370907b612025-03-20WarningsName fallback
generic name: IBUPROFEN
basic care ibuprofenIBUPROFENAmazon.com Services LLCcd15159a-9ed5-453a-9ad4-0c9688204c822025-03-19WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.ce5b0429-bbe1-47a4-af5e-0159d3cfd2c32025-03-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENCare One (Retail Business Services, LLC.)a6ce7484-7a32-4985-80bc-883c31be35252025-03-12WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
LEADER CHILDRENS IBUPROFENIBUPROFENCardinal Health 110, LLC. dba Leader913a4bd0-0784-45b4-b05e-3e7c016bbb862025-03-03WarningsName fallback
generic name: IBUPROFEN
equate ibuprofenIBUPROFENWal-Mart Stores Inc2daee8c1-d05e-406b-af65-b81bbbaa244d2025-03-03WarningsName fallback
generic name: IBUPROFEN
ibuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd02889717-204c-463b-8506-4c5cf18c77d32025-03-03WarningsName fallback
brand name: ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENBi-Martdf8aa8bf-720a-483a-b6d9-e4bf8a2d94402025-03-01WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENDiscount Drug Mart, Inc2d58d1c4-b864-6bb8-e063-6394a90a71172025-02-24WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAurobindo Pharma Limited00872852-680a-41b3-901b-b991b12a176d2025-02-14Boxed warning, Warnings, Adverse reactionsName 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