# MIUDELLA
> **NDA218201** · New Drug Application · Sponsor: SEBELA WOMENS HLTH · Approved 2025-02-24
## Drug
- **FDA Application Number:** NDA218201
- **Application type:** New Drug Application
- **Brand name:** MIUDELLA
- **Generic name:** COPPER
- **Active ingredients:** COPPER
- **Dosage form:** SYSTEM
- **Route:** INTRAUTERINE
- **Marketing status:** Prescription
- **Sponsor:** SEBELA WOMENS HLTH
- **Manufacturer:** Sebela Women's Health Inc.
- **First approval:** 2025-02-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=218201)
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