MIUDELLA (COPPER)
Summary
FDA approved MIUDELLA (COPPER) by SEBELA WOMENS HLTH. NDA (New Drug) approval (REMS) on 2025-10-01. SYSTEM, INTRAUTERINE.
Details
Source
Drug Approval
External ID
NDA218201-2
Action Date
2025-10-01
Status
Approved
Category
drug
Product Code
NDA (New Drug)
Product Description
MIUDELLA (generic: COPPER), SYSTEM, INTRAUTERINE. Application: NDA218201
Company
Context & Analysis
Frequently Asked Questions
How often does SEBELA WOMENS HLTH have FDA actions?
This is the only FDA action we have on record for SEBELA WOMENS HLTH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "NDA218201-2" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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