CEFDINIR

Post-LOE

cefdinir

Aurobindo Pharma

ANDAORALCAPSULE1 Generic Approved

Approved

Jan 2008

Lifecycle

Post-LOE

Competitive Pressure

45/100

Clinical Trials

Data completeness

4/8 — Partial

CEFDINIR (cefdinir) by Aurobindo Pharma. Approved for cephalosporin antibacterial [epc]. First approved in 2008.

Drug data last refreshed 18h ago

$0.0BPart D

Mechanism of Action

Pharmacologic Class:

Cephalosporin Antibacterial

Indications

Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.

Clinical Trials (14)

NCT00834535Phase 1Completed

Cefdinir Capsules 300 mg, Non-fasting

Started Jul 2005

32 enrolled

Healthy

NCT00835484Phase 1Completed

Cefdinir Capsules 300 mg, Fasting

Started Jul 2005

32 enrolled

Healthy

NCT00882570Phase 1Completed

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 250mg/5 ml Oral Suspension Fasting Conditions

Started Apr 2005

40 enrolled

Healthy

NCT00882700Phase 1Completed

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicef 300 mg Capsule Fasting Conditions

Started Apr 2005

28 enrolled

Healthy

NCT00882154Phase 1Completed

To Demonstrate the Relative Bioequivalence of Cefdinir and Omnicel 300 mg Capsule Fed Conditions

Started Apr 2005

28 enrolled

Healthy

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.