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 39 of 48 · 948 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IBUPROFENIBUPROFENTARGET CORPORATION8e872c8d-28e2-cd49-e053-2995a90a469f2024-01-03WarningsName fallback
brand name: IBUPROFEN
generic name: IBUPROFEN
IBUPROFEN 200 MGIBUPROFENBasic Drugs, Inc.d3351d44-2078-3adc-e053-2995a90a3c8f2024-01-03WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC59f14d2b-f48a-4c25-bea3-3dc9100898b22023-12-31WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Ibuprofen Pain Releiver/ Fever ReducerIBUPROFENAmneal Pharmaceuticals of New York LLCee241be0-35f8-4789-a71f-98de31d6a5902023-12-31WarningsName fallback
generic name: IBUPROFEN
Ibuprofen (NSAID) Pain Releiver/ Fever ReducerIBUPROFENAmneal Pharmaceuticals of New York LLCa8c6bc4e-1e48-4613-8cbf-8c5cd9d51ad02023-12-31WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENAmneal Pharmaceuticals NY LLCe07d989d-1b0e-4cc1-abf2-93c8b208a29a2023-12-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens Ibuprofen Oral SuspensionIBUPROFENDEMOULAS SUPERMARKETS INC.4ca54293-9e81-4b24-8112-734f28cd2c552023-12-29WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENBionpharma Inc.4bc6e8f2-ba95-4352-80ed-b44608fc49362023-12-27WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Dye-Free IbuprofenIBUPROFENRITE AID CORPORATIONc1c58a2d-9ffd-69d0-e053-2a95a90a57182023-12-27WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutionsf1f1e0ac-6944-4123-9e08-1df91582d4572023-12-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutions8553e29a-7f6f-4ff8-9991-836e619c504d2023-12-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENAmerican Health Packagingbc69d88b-d9af-4010-8e8f-e761a9e295a92023-12-05WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutions7152b6ce-6113-4003-bf80-aa263be693922023-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENA-S Medication Solutions400faee1-f662-470e-bcd6-7711dfaf9ba22023-11-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENChain Drug Marketing Association Inc.e210c707-2bae-44a5-93dc-459dd24fd9602023-11-20WarningsName fallback
generic name: IBUPROFEN
Childrens IbuprofenIBUPROFENChain Drug Marketing Association Inc.c7e59784-a338-4922-a806-98c7505957cd2023-11-10WarningsName fallback
generic name: IBUPROFEN
Concentrated ibuprofen infantsIBUPROFENChain Drug Marketing Association Inc.c9ae72d8-d205-4736-9bc4-2325cd77d36b2023-11-03WarningsName fallback
generic name: IBUPROFEN
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLC68d67a25-e669-47c7-8410-9f304b914ff12023-10-31WarningsName fallback
generic name: IBUPROFEN
IbuprofenIBUPROFENGeri-Care Pharmaceutical Corp0744c3ca-4224-4f6a-a033-880949b544fd2023-10-30WarningsName fallback
brand name: Ibuprofen
generic name: IBUPROFEN
IbuprofenIBUPROFENTIME CAP LABORATORIES, INC.059cb22f-f6db-5d03-e063-6294a90a9ec12023-10-27WarningsName 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