SOTYLIZE (SOTALOL HYDROCHLORIDE)
Summary
FDA approved SOTYLIZE (SOTALOL HYDROCHLORIDE) by AZURITY. NDA (New Drug) approval (Labeling) on 2024-01-12. SOLUTION, ORAL.
Details
Source
Drug Approval
External ID
NDA205108-3
Action Date
2024-01-12
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
SOTYLIZE (generic: SOTALOL HYDROCHLORIDE), SOLUTION, ORAL. Application: NDA205108
Company
Context & Analysis
AZURITY has 21 FDA actions in our database.
Frequently Asked Questions
How often does AZURITY have FDA actions?
AZURITY has 21 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 "NDA205108-3" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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