FDA.reportPublic FDA data

Application 065130

Type
ANDA
Sponsor
LUPIN PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUPRAXCEFIXIMETABLET;ORAL400MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A065130-001SUPRAXCEFIXIME400MGTABLET / ORAL2004-02-12

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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A065130-001SUPRAX400MGTABLET / ORAL2004-02-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065130-001SUPRAX400MGTABLET / ORAL2004-02-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065130-001SUPRAX400MGTABLET / ORAL2004-02-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065130-001SUPRAX400MGTABLET / ORAL2004-02-12a50c72e98297…

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
generic name: CEFIXIME
CEFIXIMECEFIXIMEREMEDYREPACK INC.d6718f02-8eea-4c2f-9aa2-65121d9a6e4c2026-07-28Warnings, Adverse reactionsName fallback
generic name: CEFIXIME
CefiximeCEFIXIMERising Pharma Holdings, Inc.b5a3c547-3bc7-4856-af9c-1bead294f5d92026-04-06Warnings, Adverse reactionsName fallback
generic name: CEFIXIME
CefiximeCEFIXIMEAurobindo Pharma Limited9cdb156f-7a99-413e-b49a-ffafaf9e93fe2026-03-25Warnings, Adverse reactionsName fallback
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
generic name: CEFIXIME
CefiximeCEFIXIMEAurobindo Pharma Limited068e6edd-a5fe-40d8-8dcf-ac82b78dced42024-02-14Warnings, Adverse reactionsName fallback
generic name: CEFIXIME
CEFIXIMECEFIXIMEAscend Laboratories, LLC6f1df975-f825-4301-87da-d7eba56a68902022-05-31Warnings, Adverse reactionsName fallback
generic name: CEFIXIME

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
27437-201SUPRAXcefiximeLupin Pharmaceuticals, Inc.ANDACurrent
27437-201SUPRAXcefiximeLupin Pharmaceuticals, Inc.ANDACurrent
54348-797SUPRAXCEFIXIMEPharmPak, Inc.ANDACurrent
54348-797SUPRAXCEFIXIMEPharmPak, Inc.ANDACurrent