General MedicationsOTICStandard
OFLOXACIN
OFLOXACIN
Standard Dose
0.3%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview OFLOXACIN is listed in Drugs@FDA under application 217903 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient OFLOXACIN Form and strength SOLUTION/DROPS;OTIC - 0.3% Sponsor CAPLIN Submission history Latest submission status date: 2024-01-05 00:00:00.
Structured Monograph
Clinical summary
Approval overview OFLOXACIN is listed in Drugs@FDA under application 217903 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient OFLOXACIN Form and strength SOLUTION/DROPS;OTIC - 0.3% Sponsor CAPLIN Submission history Latest submission status date: 2024-01-05 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.