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General MedicationsOTICStandard

OTOVEL

CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE

Standard Dose
EQ 0.3% BASE;0.025%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary

Approval overview OTOVEL is listed in Drugs@FDA under application 208251 (NDA).

Review priority: STANDARD Marketing status: Prescription Active ingredient CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE Form and strength SOLUTION/DROPS;OTIC - EQ 0.3% BASE;0.025% Sponsor LAB SALVAT Submission history Latest submission status date: 2016-04-29 00:00:00.

Structured Monograph

Clinical summary

Approval overview OTOVEL is listed in Drugs@FDA under application 208251 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient CIPROFLOXACIN HYDROCHLORIDE; FLUOCINOLONE ACETONIDE Form and strength SOLUTION/DROPS;OTIC - EQ 0.3% BASE;0.025% Sponsor LAB SALVAT Submission history Latest submission status date: 2016-04-29 00:00:00. Submission type: ORIG.

Monitoring

  • • Marketing status: Prescription
  • • Review priority: STANDARD

Interaction Notes

  • No interaction notes stored yet.