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General MedicationsORALGeneric

GEMIFLOXACIN MESYLATE

GEMIFLOXACIN MESYLATE

Standard Dose
EQ 320MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview GEMIFLOXACIN MESYLATE is listed in Drugs@FDA under application 090466 (ANDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GEMIFLOXACIN MESYLATE Form and strength TABLET;ORAL - EQ 320MG BASE Sponsor ORBION PHARMS Submission history Latest submission status date: 2024-09-20 00:00:00.

Structured Monograph

Clinical summary

Approval overview GEMIFLOXACIN MESYLATE is listed in Drugs@FDA under application 090466 (ANDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GEMIFLOXACIN MESYLATE Form and strength TABLET;ORAL - EQ 320MG BASE Sponsor ORBION PHARMS Submission history Latest submission status date: 2024-09-20 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.