CYKLX (ARTICAINE HYDROCHLORIDE)
Summary
FDA approved CYKLX (ARTICAINE HYDROCHLORIDE) by THEA PHARMA. NDA (New Drug) approval (Type 3 - New Dosage Form and Type 4 - New Combination) on 2025-08-15. SOLUTION/DROPS, OPHTHALMIC.
Details
Source
Drug Approval
External ID
NDA218643-1
Action Date
2025-08-15
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
CYKLX (generic: ARTICAINE HYDROCHLORIDE), SOLUTION/DROPS, OPHTHALMIC. Application: NDA218643
Company
Context & Analysis
THEA PHARMA has 5 FDA actions in our database.
Frequently Asked Questions
How often does THEA PHARMA have FDA actions?
THEA PHARMA has 5 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA218643-1" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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