General MedicationsOPHTHALMICStandard
TOBRADEX
DEXAMETHASONE; TOBRAMYCIN
Standard Dose
0.1%;0.3%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TOBRADEX is listed in Drugs@FDA under application 050616 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DEXAMETHASONE; TOBRAMYCIN Form and strength OINTMENT;OPHTHALMIC - 0.1%;0.3% Sponsor NOVARTIS Submission history Latest submission status date: 2021-05-14 00:00:00.
Structured Monograph
Clinical summary
Approval overview TOBRADEX is listed in Drugs@FDA under application 050616 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXAMETHASONE; TOBRAMYCIN Form and strength OINTMENT;OPHTHALMIC - 0.1%;0.3% Sponsor NOVARTIS Submission history Latest submission status date: 2021-05-14 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.