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 32 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.701ee488-c57f-a82c-e053-2991aa0af4032025-01-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen19d3af1c-9dd5-48d9-bd5c-05cc8745e8362025-01-04WarningsName fallback
generic name: IBUPROFEN
good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergen7cd838e1-85da-4510-86f0-9d8bc913e8102025-01-03WarningsName fallback
generic name: IBUPROFEN
Good Neighbor Pharmacy Childrens IbuprofenIBUPROFENAmerisource Bergenb8f43352-f771-4722-b843-f3e29f77c7c02025-01-03WarningsName fallback
generic name: IBUPROFEN
Good neighbor pharmacy ibuprofenIBUPROFENAmerisource Bergena07c45b4-dc98-4b73-a1c1-84b108cf37e92025-01-03WarningsName fallback
generic name: IBUPROFEN
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.9b02607a-6fab-5205-e053-2a95a90afa262025-01-02Name fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fc871659-ce41-1be6-e053-6294a90aa5e42025-01-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENPadagis Israel Pharmaceuticals Ltd998f2fcf-0b40-4304-929f-7f2fa42f66d02024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENTrifecta Pharmaceuticals USA LLC09972806-e064-238d-e063-6394a90a74342024-12-31WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCaf9af7f4-6314-6217-e053-2995a90a5a0f2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLCb33caad1-8d40-16f2-e053-2a95a90a1b2d2024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCc859cc7a-e13a-7df4-e053-2a95a90a47d62024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCbd1ca7af-d640-23fb-e053-2a95a90a8a982024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENAdvanced Rx Pharmacy of Tennessee, LLCf18b6a0a-e42f-083d-e053-2995a90a40e42024-12-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENSpirit Pharmaceutical LLC59c77fd3-5e67-45ec-82ad-44585390c4f32024-12-30WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLC2810122e-3c89-49a2-8dac-db3714cb7b452024-12-30WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IbuprofenIBUPROFENSpirit Pharmaceutical LLCa96d012e-b132-4e99-b84b-ccd3a9a05cbb2024-12-30WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Cabinet Pain Reliever and Fever ReducerIBUPROFENSpirit Pharmaceutical LLCe172a8d8-779d-4ad9-b6b0-08a198a580342024-12-30WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAurohealth LLC09bd3935-526d-4ad1-898a-4f0d9499ebb92024-12-26WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens Ibuprofen Oral SuspensionIBUPROFENChain Drug Marketing Association, Inc.f0959369-890e-403e-8a98-4eda340a07832024-12-23WarningsName 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