DEXTENZA (DEXAMETHASONE)
Summary
FDA approved DEXTENZA (DEXAMETHASONE) by OCULAR THERAPEUTIX. NDA (New Drug) approval (Efficacy) on 2025-04-07. INSERT, OPHTHALMIC.
Details
Source
Drug Approval
External ID
NDA208742-13
Action Date
2025-04-07
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
DEXTENZA (generic: DEXAMETHASONE), INSERT, OPHTHALMIC. Application: NDA208742
Company
Context & Analysis
Frequently Asked Questions
How often does OCULAR THERAPEUTIX have FDA actions?
This is the only FDA action we have on record for OCULAR THERAPEUTIX in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA208742-13" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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