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General MedicationsOTICGeneric

XTORO

FINAFLOXACIN

Standard Dose
0.3%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Discontinued
Summary

Approval overview XTORO is listed in Drugs@FDA under application 206307 (NDA).

Review priority: STANDARD Marketing status: Discontinued Active ingredient FINAFLOXACIN Form and strength SUSPENSION/DROPS;OTIC - 0.3% Sponsor FONSECA BIOSCIENCES Submission history Latest submission status date: 2026-03-18 00:00:00.

Structured Monograph

Clinical summary

Approval overview XTORO is listed in Drugs@FDA under application 206307 (NDA). Review priority: STANDARD Marketing status: Discontinued Active ingredient FINAFLOXACIN Form and strength SUSPENSION/DROPS;OTIC - 0.3% Sponsor FONSECA BIOSCIENCES Submission history Latest submission status date: 2026-03-18 00:00:00. Submission type: SUPPL.

Monitoring

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

Interaction Notes

  • No interaction notes stored yet.