General MedicationsOPHTHALMICStandard
TOBRADEX ST
DEXAMETHASONE; TOBRAMYCIN
Standard Dose
0.05%;0.3%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TOBRADEX ST is listed in Drugs@FDA under application 050818 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DEXAMETHASONE; TOBRAMYCIN Form and strength SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3% Sponsor HARROW EYE Submission history Latest submission status date: 2026-03-17 00:00:00.
Structured Monograph
Clinical summary
Approval overview TOBRADEX ST is listed in Drugs@FDA under application 050818 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXAMETHASONE; TOBRAMYCIN Form and strength SUSPENSION/DROPS;OPHTHALMIC - 0.05%;0.3% Sponsor HARROW EYE Submission history Latest submission status date: 2026-03-17 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.