General MedicationsORALGeneric

FACTIVE

GEMIFLOXACIN MESYLATE

Standard Dose

EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Max Dose

Refer to approved labeling

Primary Use

Review priority: STANDARD Marketing status: Discontinued

Summary

Approval overview FACTIVE is listed in Drugs@FDA under application 021158 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient GEMIFLOXACIN MESYLATE Form and strength TABLET;ORAL - EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor LG CHEM LTD Submission history Latest submission status date: 2019-05-03 00:00:00.

Structured Monograph

Clinical summary

Approval overview FACTIVE is listed in Drugs@FDA under application 021158 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient GEMIFLOXACIN MESYLATE Form and strength TABLET;ORAL - EQ 320MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor LG CHEM LTD Submission history Latest submission status date: 2019-05-03 00:00:00. Submission type: SUPPL.

Monitoring

• Marketing status: Discontinued
• Review priority: STANDARD

Interaction Notes

No interaction notes stored yet.