FDA.reportPublic FDA data

Application 218691

Type
ANDA
Sponsor
FDC LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFIXIMECEFIXIMEFOR SUSPENSION;ORAL100MG/5MLNoNo
002CEFIXIMECEFIXIMEFOR SUSPENSION;ORAL200MG/5MLNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A218691-001CEFIXIMECEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2026-05-14
A218691-002CEFIXIMECEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2026-05-14

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A218691-001AB
A218691-002AB

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218691-001CEFIXIME100MG/5MLFOR SUSPENSION / ORALAB2026-05-14a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218691-002CEFIXIME200MG/5MLFOR SUSPENSION / ORALAB2026-05-14a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218691-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A218691-002AB1a50c72e98297…

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 1 of 1 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CEFIXIMECEFIXIMEREMEDYREPACK INC.3194433c-c04e-442b-9668-fbeb0a15bac72026-08-05Warnings, Adverse reactionsName fallback
brand name: CEFIXIME
generic name: CEFIXIME
CEFIXIMECEFIXIMEREMEDYREPACK INC.d6718f02-8eea-4c2f-9aa2-65121d9a6e4c2026-07-28Warnings, Adverse reactionsName fallback
brand name: CEFIXIME
generic name: CEFIXIME
CefiximeCEFIXIMERising Pharma Holdings, Inc.b5a3c547-3bc7-4856-af9c-1bead294f5d92026-04-06Warnings, Adverse reactionsName fallback
brand name: Cefixime
generic name: CEFIXIME
CefiximeCEFIXIMEAurobindo Pharma Limited9cdb156f-7a99-413e-b49a-ffafaf9e93fe2026-03-25Warnings, Adverse reactionsName fallback
brand name: Cefixime
generic name: CEFIXIME
Cefixime 400 mgCEFIXIMEHealth Department, Oklahoma Statef0fdb14b-e4fb-707e-e053-2a95a90a90492025-12-20WarningsName fallback
generic name: CEFIXIME
CEFIXIMECEFIXIMELupin Pharmaceuticals, Inc.6d68dbd9-7d75-4ff1-91db-79ff8ae879ec2025-10-14Warnings, Adverse reactionsName fallback
brand name: CEFIXIME
generic name: CEFIXIME
CefiximeCEFIXIMEAurobindo Pharma Limited068e6edd-a5fe-40d8-8dcf-ac82b78dced42024-02-14Warnings, Adverse reactionsName fallback
brand name: Cefixime
generic name: CEFIXIME
CEFIXIMECEFIXIMEAscend Laboratories, LLC6f1df975-f825-4301-87da-d7eba56a68902022-05-31Warnings, Adverse reactionsName fallback
brand name: CEFIXIME
generic name: CEFIXIME