FDA.reportPublic FDA data

Application 065409

Type
ANDA
Sponsor
AUROBINDO PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CEFPODOXIME PROXETILCEFPODOXIME PROXETILFOR SUSPENSION;ORALEQ 50MG BASE/5MLNoNo
002CEFPODOXIME PROXETILCEFPODOXIME PROXETILFOR SUSPENSION;ORALEQ 100MG BASE/5MLNoYes

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

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
A065409-001CEFPODOXIME PROXETILCEFPODOXIME PROXETILEQ 50MG BASE/5MLFOR SUSPENSION / ORAL2007-06-08
A065409-002CEFPODOXIME PROXETILCEFPODOXIME PROXETILEQ 100MG BASE/5MLFOR SUSPENSION / ORALRS2007-06-08

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A065409-001CEFPODOXIME PROXETILEQ 50MG BASE/5MLFOR SUSPENSION / ORAL2007-06-08f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A065409-002CEFPODOXIME PROXETILEQ 100MG BASE/5MLFOR SUSPENSION / ORALRS2007-06-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A065409-001CEFPODOXIME PROXETILEQ 50MG BASE/5MLFOR SUSPENSION / ORAL2007-06-08e64feba35796…
2022-09-29 23:25 UTC2022-09A065409-002CEFPODOXIME PROXETILEQ 100MG BASE/5MLFOR SUSPENSION / ORALRS2007-06-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065409-001CEFPODOXIME PROXETILEQ 50MG BASE/5MLFOR SUSPENSION / ORAL2007-06-08cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A065409-002CEFPODOXIME PROXETILEQ 100MG BASE/5MLFOR SUSPENSION / ORALRS2007-06-08cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065409-001CEFPODOXIME PROXETILEQ 50MG BASE/5MLFOR SUSPENSION / ORAL2007-06-08a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A065409-002CEFPODOXIME PROXETILEQ 100MG BASE/5MLFOR SUSPENSION / ORALRS2007-06-08a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cefpodoxime ProxetilCEFPODOXIME PROXETILRising Pharma Holdings, Inc.edf589b2-f796-4522-a5e6-2bd0a833922f2025-06-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065409
application number: ANDA065409
ndc (product): 64980-403
ndc (product): 64980-402
Cefpodoxime ProxetilCEFPODOXIME PROXETILNorthStar Rx LLC5310de78-22c3-4bee-9956-854e767b6bef2024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065409
application number: ANDA065409
ndc (product): 16714-403
ndc (product): 16714-402
Cefpodoxime ProxetilCEFPODOXIME PROXETILAurobindo Pharma Limited63777889-d306-4fc3-88da-b24859040ef42024-01-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 065409
application number: ANDA065409
ndc (product): 65862-140
ndc (product): 65862-141

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 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
16714-402Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-402Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-402Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-402Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-403Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-403Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-403Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
16714-403Cefpodoxime ProxetilCefpodoxime ProxetilNorthStar Rx LLCANDACurrent
64980-402Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-402Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-402Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-403Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-403Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
64980-403Cefpodoxime ProxetilCefpodoxime ProxetilRising Pharmaceuticals, Inc.ANDACurrent
65862-140Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-140Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-140Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-141Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-141Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent
65862-141Cefpodoxime ProxetilCefpodoxime ProxetilAurobindo Pharma LimitedANDACurrent