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General MedicationsORALGeneric

CEDAX

CEFTIBUTEN DIHYDRATE

Standard Dose
EQ 400MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview CEDAX is listed in Drugs@FDA under application 050685 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient CEFTIBUTEN DIHYDRATE Form and strength CAPSULE;ORAL - EQ 400MG BASE Sponsor BURKE THERAP Submission history Latest submission status date: 2010-11-04 00:00:00.

Structured Monograph

Clinical summary

Approval overview CEDAX is listed in Drugs@FDA under application 050685 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient CEFTIBUTEN DIHYDRATE Form and strength CAPSULE;ORAL - EQ 400MG BASE Sponsor BURKE THERAP Submission history Latest submission status date: 2010-11-04 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.