General MedicationsOPHTHALMICStandard
DEXTENZA
DEXAMETHASONE
Standard Dose
0.4MG
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview DEXTENZA is listed in Drugs@FDA under application 208742 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient DEXAMETHASONE Form and strength INSERT;OPHTHALMIC - 0.4MG Sponsor OCULAR THERAPEUTIX Submission history Latest submission status date: 2025-04-07 00:00:00.
Structured Monograph
Clinical summary
Approval overview DEXTENZA is listed in Drugs@FDA under application 208742 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient DEXAMETHASONE Form and strength INSERT;OPHTHALMIC - 0.4MG Sponsor OCULAR THERAPEUTIX Submission history Latest submission status date: 2025-04-07 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.