FDA.reportPublic FDA data

Application 050674

Type
NDA
Sponsor
PHARMACIA AND UPJOHN

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VANTINCEFPODOXIME PROXETILTABLET;ORALEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002VANTINCEFPODOXIME PROXETILTABLET;ORALEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

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
N050674-001VANTINCEFPODOXIME PROXETILEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07
N050674-002VANTINCEFPODOXIME PROXETILEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07

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 UTC2022-10N050674-001VANTINEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N050674-002VANTINEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N050674-001VANTINEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07e64feba35796…
2022-09-29 23:25 UTC2022-09N050674-002VANTINEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050674-001VANTINEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N050674-002VANTINEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050674-001VANTINEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N050674-002VANTINEQ 200MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD1992-08-07a50c72e98297…

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 · 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CEFPODOXIME PROXETILCEFPODOXIME PROXETILRedpharm Drug59d848e9-de7a-669b-e063-6394a90a2b352026-08-25Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILSandoz Inc8519a9d8-7106-4545-bc58-859ee9a6708e2026-07-30Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILREMEDYREPACK INC.dae9cbf2-65b5-49fa-898b-924c39b86c572026-06-04Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILRising Pharma Holdings, Inc.edf589b2-f796-4522-a5e6-2bd0a833922f2025-06-06Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILGolden State Medical Supply, Inc.fb313728-09f1-aff8-e053-6394a90a30a82025-02-18Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILNuCare Pharmaceuticals,Inc.fe827f61-9336-72e7-e053-6394a90af75f2025-02-06Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILNuCare Pharmaceuticals,Inc.1b405104-650b-c8e3-e063-6294a90a9e8a2024-06-19Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
CEFPODOXIME PROXETILCEFPODOXIME PROXETILCronus Pharma LLCbc9c338c-1fc7-4bc2-a357-a78e433cbe9d2024-01-04Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILNorthStar Rx LLC5310de78-22c3-4bee-9956-854e767b6bef2024-01-04Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILAurobindo Pharma Limited63777889-d306-4fc3-88da-b24859040ef42024-01-04Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
CEFPODOXIME PROXETILCEFPODOXIME PROXETILAurobindo Pharma Limitedc36f2137-98bb-4583-89f7-6bce9582c4652024-01-03Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
CEFPODOXIME PROXETILCEFPODOXIME PROXETILNorthStar Rx LLC4587a7c1-cd6c-4946-a0dd-fcfe0c8504b92024-01-03Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILAmici Pharmaceuticals, LLC.9d6d7f50-9838-47e3-8214-53e2dbeeadea2023-07-13Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILAscend Laboratories, LLCce5646cb-a450-4c2c-8499-6ecf71b12b0e2023-04-14Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL
Cefpodoxime ProxetilCEFPODOXIME PROXETILAscend Laboratories, LLC5d5ca5b6-282b-4683-908c-8547822557392022-05-20Warnings, Adverse reactionsName fallback
generic name: CEFPODOXIME PROXETIL

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
39093SUPPL2013-06-25
30259SUPPL2013-06-24
30258SUPPL2007-06-07
18003SUPPL2007-06-07
39092SUPPL2004-06-07
7970SUPPL2004-06-07
22177SUPPL1998-11-20
7969SUPPL1998-11-20