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General MedicationsORALGeneric

CEDAX

CEFTIBUTEN DIHYDRATE

Standard Dose
EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview CEDAX is listed in Drugs@FDA under application 050686 (NDA).

Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs.

Structured Monograph

Clinical summary

Approval overview CEDAX is listed in Drugs@FDA under application 050686 (NDA). Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. Review priority: STANDARD Marketing status: Discontinued Active ingredient CEFTIBUTEN DIHYDRATE Form and strength FOR SUSPENSION;ORAL - EQ 90MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor BURKE THERAP Submission history Latest submission status date: 2011-03-11 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.