TheraRadar
Data updated: May 26, 2026

BANAN (cefpodoxime proxetil)

Infectious Disease Approved 1992-08-07
Jump to: Indications Approvals Trials Competitors Safety Patents
4
Indications
--
Phase 3 Trials
33
Years on Market

Details

Status
Discontinued
First Approved
1992-08-07
Routes
ORAL
Dosage Forms
TABLET, FOR SUSPENSION

Companies

SANKYO
Active Ingredient: CEFPODOXIME PROXETIL

BANAN Approval History

1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
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2015
2016
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2020
2021
2022
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2026
Original
New Indication
New Form
Label Update
54 FDA actions from 1992 to 2000 · 2 indication expansions
Feb 2000 SUPPL
Label · Labeling
FDA Letter Label
May 1999 SUPPL
Label · Labeling
May 1999 SUPPL
Label · Labeling

What BANAN Treats

4 FDA approvals

Originally approved for its first indication in 1992 . Covers 4 distinct patient populations.

  • Other (4)
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT03491748 CS0282-2017-0001 1010452 Ph 1 completed A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics (PK, the Measure of How the Human Body Processes a Substance) of ETX0282 When Administered Orally to Healthy Participants
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

BANAN FDA Label Details

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Data Sources

FDA Approval: NDA050687 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.