TheraRadar
Data updated: May 26, 2026

OMNICEF (cefdinir)

Infectious Disease Approved 1997-12-04
Jump to: Indications Approvals Trials Competitors Safety Patents
3
Indications
--
Phase 3 Trials
28
Years on Market

Details

Status
Discontinued
First Approved
1997-12-04
Routes
ORAL
Dosage Forms
FOR SUSPENSION, CAPSULE

Companies

AbbVie
Active Ingredient: CEFDINIR

OMNICEF Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
36 FDA actions from 1997 to 2015 · 2 indication expansions
Nov 2015 SUPPL
Label · Labeling
FDA Letter Label
Dec 2008 SUPPL
Label · Labeling
FDA Letter Label
Sep 2007 SUPPL
Label · Labeling
FDA Letter Label

What OMNICEF Treats

3 FDA approvals

Originally approved for its first indication in 1997 . Covers 3 distinct patient populations.

  • Other (3)
📋

Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02891915 results posted 14-0079 HHSN272201300023I Ph 4 completed Trial to Evaluate Beta-Lactam Antimicrobial Therapy of Community Acquired Pneumonia in Children
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

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.

OMNICEF FDA Label Details

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Data Sources

FDA Approval: NDA050749 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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