DROXIA (HYDROXYUREA)
Summary
FDA approved DROXIA (HYDROXYUREA) by WAYLIS THERAP. NDA (New Drug) approval (Labeling) on 2024-06-20. CAPSULE, ORAL.
Details
Source
Drug Approval
External ID
NDA016295-59
Action Date
2024-06-20
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
DROXIA (generic: HYDROXYUREA), CAPSULE, ORAL. Application: NDA016295
Company
Context & Analysis
WAYLIS THERAP has 4 FDA actions in our database.
Frequently Asked Questions
How often does WAYLIS THERAP have FDA actions?
WAYLIS THERAP has 4 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 "NDA016295-59" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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