ARIXTRA (FONDAPARINUX SODIUM)
Summary
FDA approved ARIXTRA (FONDAPARINUX SODIUM) by MYLAN IRELAND LTD. NDA (New Drug) approval (Efficacy) on 2024-12-23. SOLUTION, SUBCUTANEOUS.
Details
Source
Drug Approval
External ID
NDA021345-52
Action Date
2024-12-23
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
ARIXTRA (generic: FONDAPARINUX SODIUM), SOLUTION, SUBCUTANEOUS. Application: NDA021345
Company
Context & Analysis
MYLAN IRELAND LTD has 2 FDA actions in our database.
Frequently Asked Questions
How often does MYLAN IRELAND LTD have FDA actions?
MYLAN IRELAND LTD has 2 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 "NDA021345-52" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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